Канал: U.S. Food and Drug Administration

November 19, 2024 Joint Meeting of the DSaRM and the PDAC

November 19, 2024 Joint Meeting of the DSaRM and the PDAC

Conversations on Cancer - Pediatric Cancers: Navigating the Challenges Together

Conversations on Cancer - Pediatric Cancers: Navigating the Challenges Together

Antibiotics: Know When and How to Use Them

Antibiotics: Know When and How to Use Them

Dr. Mina Tanaka on Stigma and Requirements for Prescribing MOUD

Dr. Mina Tanaka on Stigma and Requirements for Prescribing MOUD

Harm Reduction in MOUD from Dr. Mina Tanaka

Harm Reduction in MOUD from Dr. Mina Tanaka

A rewarding patient story about an expectant father treated with MOUD

A rewarding patient story about an expectant father treated with MOUD

The Science of Generics: An FDA Researcher's Perspective | Researching FDA

The Science of Generics: An FDA Researcher's Perspective | Researching FDA

More Information on Recalls | FDA In Your Day Ep. 16

More Information on Recalls | FDA In Your Day Ep. 16

FDA Drug Topic Webinar - Bad Ad Program

FDA Drug Topic Webinar - Bad Ad Program

MEDIA CALL: FDA’s Proposed Order on Phenylephrine – 11/7/2024

MEDIA CALL: FDA’s Proposed Order on Phenylephrine – 11/7/2024

Flour is a Raw Food! | FDA In Your Day Ep. 15

Flour is a Raw Food! | FDA In Your Day Ep. 15

FDA Clinical Investigator Training Course (CITC) 2024 – Promo Video

FDA Clinical Investigator Training Course (CITC) 2024 – Promo Video

REACHing Communities Video Series – An Interview with Myra Parker, J.D., M.P.H., Ph.D.

REACHing Communities Video Series – An Interview with Myra Parker, J.D., M.P.H., Ph.D.

Innovating Generic Drug Research | Researching FDA

Innovating Generic Drug Research | Researching FDA

October 31, 2024 Endocrinologic and Metabolic Drugs Advisory Committee

October 31, 2024 Endocrinologic and Metabolic Drugs Advisory Committee

How to Safely Dispose of Unused or Expired Medicine

How to Safely Dispose of Unused or Expired Medicine

Cómo deshacerse de manera segura de medicamentos no utilizados o caducados, 40 segundos

Cómo deshacerse de manera segura de medicamentos no utilizados o caducados, 40 segundos

How to Safely Dispose of Unused or Expired Medicine, 60 Seconds

How to Safely Dispose of Unused or Expired Medicine, 60 Seconds

How to Safely Dispose of Unused or Expired Medicine, 30 Seconds

How to Safely Dispose of Unused or Expired Medicine, 30 Seconds

Cómo deshacerse de manera segura de medicamentos no utilizados o caducados

Cómo deshacerse de manera segura de medicamentos no utilizados o caducados

Cómo deshacerse de manera segura de medicamentos no utilizados o caducados, 75 segundos

Cómo deshacerse de manera segura de medicamentos no utilizados o caducados, 75 segundos

¿Estás comiendo demasiada sal? 4 maneras de reducir la sal gradualmente...

¿Estás comiendo demasiada sal? 4 maneras de reducir la sal gradualmente...

Food Safety Tips for the Holidays! | FDA In Your Day Ep. 14

Food Safety Tips for the Holidays! | FDA In Your Day Ep. 14

October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee (PCAC)

October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee (PCAC)

Understanding Drug Recalls with Dr. Ileana Elder

Understanding Drug Recalls with Dr. Ileana Elder

The Science of Generics: An FDA Researcher's Perspective | Researching FDA

The Science of Generics: An FDA Researcher's Perspective | Researching FDA

Conversations on Cancer Program, Pazdur+25—Celebrating a Silver FDA Anniversary

Conversations on Cancer Program, Pazdur+25—Celebrating a Silver FDA Anniversary

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 3

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 3

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 2

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 2

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 1

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 1

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 4

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 4

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 3

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 3

Global IDMP Implementation - Getting Closer to the Goal

Global IDMP Implementation - Getting Closer to the Goal

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 2

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 2

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 1

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 1

ICH M12 Drug-Drug Interaction Studies Final Guidance

ICH M12 Drug-Drug Interaction Studies Final Guidance

Biosimilars: Totality of the Evidence in Biosimilar Development

Biosimilars: Totality of the Evidence in Biosimilar Development

Biosimilars: The Purple Book

Biosimilars: The Purple Book

Biosimilars: Comparative Analytical Assessment

Biosimilars: Comparative Analytical Assessment

A Walk-Through of FDA’s Purple Book: Database of Biological Products

A Walk-Through of FDA’s Purple Book: Database of Biological Products

October 10, 2024 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC)

October 10, 2024 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC)

187th Vaccines and Related Biological Products Advisory Committee Meeting

187th Vaccines and Related Biological Products Advisory Committee Meeting

STEM at CBER

STEM at CBER

Voluntary Sodium Reduction Goals (Edition 2) Draft Guidance and Preliminary Assessment of Progress

Voluntary Sodium Reduction Goals (Edition 2) Draft Guidance and Preliminary Assessment of Progress

FREE COVID Tests Are Back! How to Order Yours Today | FDA In Your Day Ep. 13

FREE COVID Tests Are Back! How to Order Yours Today | FDA In Your Day Ep. 13

REACHing Communities Video Series – An Interview with Perla Nunes

REACHing Communities Video Series – An Interview with Perla Nunes

FDA’s Modernized Office of the Chief Scientist

FDA’s Modernized Office of the Chief Scientist

Your Fall Vaccine Game Plan: COVID, Flu, & RSV Protection | FDA In Your Day Ep. 12

Your Fall Vaccine Game Plan: COVID, Flu, & RSV Protection | FDA In Your Day Ep. 12

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 – Part 2

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 – Part 2

FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CDRH Segment

FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CDRH Segment

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 – Part 1

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 – Part 1

FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CBER Segment

FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CBER Segment

FDA | NIH: Regulatory Do’s and Don'ts: Tips from FDA – CDER Segment

FDA | NIH: Regulatory Do’s and Don'ts: Tips from FDA – CDER Segment

Clinicians Connect: Conversations with FDA's Chief Medical Officer on Overdose Prevention

Clinicians Connect: Conversations with FDA's Chief Medical Officer on Overdose Prevention

Sickle Cell Disease: A Spotlight on Women

Sickle Cell Disease: A Spotlight on Women

LEADER 3D: Challenges, Strategies & Regulatory Considerations for Rare Disease Clinical Trial Design

LEADER 3D: Challenges, Strategies & Regulatory Considerations for Rare Disease Clinical Trial Design

Utilizing Generic Drug Awareness to Improve Patient Outcomes with Dr. Sarah Ibrahim

Utilizing Generic Drug Awareness to Improve Patient Outcomes with Dr. Sarah Ibrahim

September 26, 2024 Meeting of the Oncologic Drugs Advisory Committee (ODAC)

September 26, 2024 Meeting of the Oncologic Drugs Advisory Committee (ODAC)

Some Vaccines are too New? | FDA In Your Day Ep. 11

Some Vaccines are too New? | FDA In Your Day Ep. 11

Advancing Generic Drug Development: Translating Science to Approval 2024 (Day 2)

Advancing Generic Drug Development: Translating Science to Approval 2024 (Day 2)

CTP PREXISTING PROGRAM: PART 2 OF 3: PREPARING AND SUBMITTING A STANDALONE PRE-EXISTING SUBMISSION

CTP PREXISTING PROGRAM: PART 2 OF 3: PREPARING AND SUBMITTING A STANDALONE PRE-EXISTING SUBMISSION

Importing FDA-Regulated Products: Seafood

Importing FDA-Regulated Products: Seafood

Advancing Generic Drug Development: Translating Science to Approval 2024 (Day 1)

Advancing Generic Drug Development: Translating Science to Approval 2024 (Day 1)

National Forensic Chemistry Center Revitalized

National Forensic Chemistry Center Revitalized

Navigating the Quality Management System Regulation

Navigating the Quality Management System Regulation

An Overview of the Quality Management System Regulation

An Overview of the Quality Management System Regulation

Bench to Bedside Chats: Guidance for Industry CGMP for Phase 1 Investigational Drugs

Bench to Bedside Chats: Guidance for Industry CGMP for Phase 1 Investigational Drugs

Vaccines and Related Biological Products Advisory Committee

Vaccines and Related Biological Products Advisory Committee

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) ...

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) ...

Conversations on Cancer: National Hispanic/Latino Family Cancer Awareness Week

Conversations on Cancer: National Hispanic/Latino Family Cancer Awareness Week

Total Product Lifecycle Advisory Program (TAP) Engagement with Device Developers

Total Product Lifecycle Advisory Program (TAP) Engagement with Device Developers

Semana Nacional de Concientización sobre el Cáncer en las Familias Hispanas/Latinas

Semana Nacional de Concientización sobre el Cáncer en las Familias Hispanas/Latinas

Programa da Semana Nacional de Conscientização sobre o Câncer em Famílias Hispânicas/Latinas

Programa da Semana Nacional de Conscientização sobre o Câncer em Famílias Hispânicas/Latinas

FDA에 관한 사실 2부, FDA가 승인한 것과 승인하지 않은 것에 대한 10가지 사실 #FDAFacts

FDA에 관한 사실 2부, FDA가 승인한 것과 승인하지 않은 것에 대한 10가지 사실 #FDAFacts

Sự thật Từ FDA Phần 2, 10 sự thật về những gì FDA chấp thuận và không chấp thuận #FDAFacts

Sự thật Từ FDA Phần 2, 10 sự thật về những gì FDA chấp thuận và không chấp thuận #FDAFacts

Mga FDA Fact Bahagi 2 10 Fact tungkol sa Ano ang Inaaprubahan at Hindi Inaaprubahan ng FDA

Mga FDA Fact Bahagi 2 10 Fact tungkol sa Ano ang Inaaprubahan at Hindi Inaaprubahan ng FDA

FDA 事实第 2 部分，关于 FDA 批准和未批准事项的 10 个事实 #FDA 事实

FDA 事实第 2 部分，关于 FDA 批准和未批准事项的 10 个事实 #FDA 事实

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 4

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 4

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 3

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 3

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 2

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 2

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 1

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 1

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 3

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 3

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 2

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 2

FDA Omics Days 2024: Public morning sessions

FDA Omics Days 2024: Public morning sessions

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 1

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 1

FDA Omics Days 2024: Public afternoon sessions

FDA Omics Days 2024: Public afternoon sessions

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 - Keynote and Plenary

Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 - Keynote and Plenary

September 13, 2024 Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC)

September 13, 2024 Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC)

Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice - Part 2

Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice - Part 2

Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice - Part 1

Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice - Part 1

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024

20. Notificar una queja

20. Notificar una queja

A Conversation with Dr. Rigoberto Delgado & Dr. Fabian Sandoval

A Conversation with Dr. Rigoberto Delgado & Dr. Fabian Sandoval

Bench to Bedside Chat Pharmacology and Dose Optimization for First-in-Human Oncology Trials

Bench to Bedside Chat Pharmacology and Dose Optimization for First-in-Human Oncology Trials

19. Las vacunas de ARNm

19. Las vacunas de ARNm

ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA

ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA

18. Recolección de sangre y componentes

18. Recolección de sangre y componentes

20. If you have a complaint about a product regulated by the FDA the agency wants to👂about it.

20. If you have a complaint about a product regulated by the FDA the agency wants to👂about it.

Health Equity Forum Podcast: Improving the Quality of Life for People with Sickle Cell

Health Equity Forum Podcast: Improving the Quality of Life for People with Sickle Cell

FDA In Your Day: Food Safety

FDA In Your Day: Food Safety

FDA In Your Day: Food Safety | FDA In Your Day Ep. 10

FDA In Your Day: Food Safety | FDA In Your Day Ep. 10

September 9, 2024 Meeting of the Antimicrobial Drugs Advisory Committee (AMDAC)

September 9, 2024 Meeting of the Antimicrobial Drugs Advisory Committee (AMDAC)

17. Científicos de la FDA

17. Científicos de la FDA

19. mRNA vaccines were developed based on decades of scientific study at NIH...#FDAFacts

19. mRNA vaccines were developed based on decades of scientific study at NIH...#FDAFacts

16. Alimentos y medicamentos para animales

16. Alimentos y medicamentos para animales

Why CVM? Diverse Experiences, One Vision

Why CVM? Diverse Experiences, One Vision

Join CVM: Real Stories, Real Impact

Join CVM: Real Stories, Real Impact

CVM Journeys_Diverse Voices, Shared Missions

CVM Journeys_Diverse Voices, Shared Missions

18. The FDA regulates the collection of blood and blood components. #FDAFacts

18. The FDA regulates the collection of blood and blood components. #FDAFacts

15. Farmacias virtuales

15. Farmacias virtuales

17. More than 12,000 highly qualified scientists work at the FDA. #FDAFacts

17. More than 12,000 highly qualified scientists work at the FDA. #FDAFacts

¿Qué puede hacer para ayudar durante las interrupciones en el suministro de medicamentos?

¿Qué puede hacer para ayudar durante las interrupciones en el suministro de medicamentos?

¿Tiene dificultades para encontrar algunos de sus medicamentos que toma regularmente?

¿Tiene dificultades para encontrar algunos de sus medicamentos que toma regularmente?

Explicación general del vapeo por pediatras

Explicación general del vapeo por pediatras

Recursos disponibles para abordar el uso de cigarrillos electrónicos en los jóvenes

Recursos disponibles para abordar el uso de cigarrillos electrónicos en los jóvenes

Cómo usar el Centro de Recursos para la Prevención y la Educación sobre el Vapeo de la FDA

Cómo usar el Centro de Recursos para la Prevención y la Educación sobre el Vapeo de la FDA

14. Etiqueta de información nutricional

14. Etiqueta de información nutricional

16. The FDA regulates foods and drugs for animals. #FDAfacts

16. The FDA regulates foods and drugs for animals. #FDAfacts

Improving the Quality of Life for People with Sickle Cell Disease

Improving the Quality of Life for People with Sickle Cell Disease

13. Participación en ensayos clínicos

13. Participación en ensayos clínicos

Conozca qué medicamentos son adecuados para sus alergias estacionales

Conozca qué medicamentos son adecuados para sus alergias estacionales

FDA In Your Day: Hurricane Preparedness

FDA In Your Day: Hurricane Preparedness

FDA In Your Day: Hurricane Preparedness | FDA In Your Day Ep. 9

FDA In Your Day: Hurricane Preparedness | FDA In Your Day Ep. 9

15. The FDA doesn't license pharmacies, including online pharmacies. #FDAFacts

15. The FDA doesn't license pharmacies, including online pharmacies. #FDAFacts

12. Productos homeopáticos

12. Productos homeopáticos

14. The FDA requires that manufacturers provide helpful nutrition info on food labels. #FDAFacts

14. The FDA requires that manufacturers provide helpful nutrition info on food labels. #FDAFacts

FDA In Your Day: Lyme Disease

FDA In Your Day: Lyme Disease

FDA In Your Day: Lyme Disease | FDA In Your Day Ep. 8

FDA In Your Day: Lyme Disease | FDA In Your Day Ep. 8

13. The FDA encourages diverse participation in clinical trials. #FDAFacts

13. The FDA encourages diverse participation in clinical trials. #FDAFacts

11. Rellenos dérmicos

11. Rellenos dérmicos

ESG NextGen Invited User Demo

ESG NextGen Invited User Demo

12. There are no FDA-approved homeopathic products. #FDAFacts

12. There are no FDA-approved homeopathic products. #FDAFacts

11. The FDA regulates dermal fillers as medical devices. #FDAFacts

11. The FDA regulates dermal fillers as medical devices. #FDAFacts

Real-World Data and Evidence Generation with Dr. Hilary Marston

Real-World Data and Evidence Generation with Dr. Hilary Marston

Basic Introduction to Mushroom Growing, Harvesting, Packing and Holding

Basic Introduction to Mushroom Growing, Harvesting, Packing and Holding

Medicamentos biosimilares: Lo que los pacientes deben saber

Medicamentos biosimilares: Lo que los pacientes deben saber

FDA D.I.S.C.O. Burst Edition: FDA approvals of Augtyro (repotrectinib) for NTRK gene fusion-posit...

FDA D.I.S.C.O. Burst Edition: FDA approvals of Augtyro (repotrectinib) for NTRK gene fusion-posit...

Get the Facts on Chemicals in Foods with the U.S. Food and Drug Administration

Get the Facts on Chemicals in Foods with the U.S. Food and Drug Administration

Get the Facts on Chemicals in Foods with the U.S. Food and Drug Administration

Get the Facts on Chemicals in Foods with the U.S. Food and Drug Administration

What is Accelerated Approval?

What is Accelerated Approval?

Importance of Minority Students in Oncology Careers

Importance of Minority Students in Oncology Careers

Importance of Scheduling Updating Cancer Screenings

Importance of Scheduling Updating Cancer Screenings

How are Cancer Drugs Approved?

How are Cancer Drugs Approved?

What is OCE?

What is OCE?

Eating Too Much Salt? Ways to Cut Back…Gradually

Eating Too Much Salt? Ways to Cut Back…Gradually

Clinicians Connect: Conversations with FDA's Chief Medical Officer: 2024 Respiratory Virus Season

Clinicians Connect: Conversations with FDA's Chief Medical Officer: 2024 Respiratory Virus Season

¿Qué hace la FDA después de que aprueba los medicamentos? (30 segundos)

¿Qué hace la FDA después de que aprueba los medicamentos? (30 segundos)

¿Cómo aprueba la FDA los medicamentos nuevos? (30 segundos)

¿Cómo aprueba la FDA los medicamentos nuevos? (30 segundos)

¿Cuál es el papel de la FDA en la regulación de los medicamentos? (30 segundos)

¿Cuál es el papel de la FDA en la regulación de los medicamentos? (30 segundos)

What does the FDA do after drugs are approved? (30 seconds)

What does the FDA do after drugs are approved? (30 seconds)

What does the FDA do after drugs are approved? (15 seconds)

What does the FDA do after drugs are approved? (15 seconds)

How does the FDA approve new drugs? (30 seconds)

How does the FDA approve new drugs? (30 seconds)

How does the FDA approve new drugs? (15 seconds)

How does the FDA approve new drugs? (15 seconds)

What is FDA’s role in regulating drugs? (30 seconds)

What is FDA’s role in regulating drugs? (30 seconds)

What is FDA’s role in regulating drugs? (15 seconds)

What is FDA’s role in regulating drugs? (15 seconds)

¿Cuál es el papel de la FDA en la regulación de los medicamentos?

¿Cuál es el papel de la FDA en la regulación de los medicamentos?

¿Cómo aprueba la FDA los medicamentos nuevos?

¿Cómo aprueba la FDA los medicamentos nuevos?

¿Qué hace la FDA después de que aprueba los medicamentos?

¿Qué hace la FDA después de que aprueba los medicamentos?

August 2, 2024 Meeting of the Genetic Metabolic Diseases Advisory Committee (GeMDAC)

August 2, 2024 Meeting of the Genetic Metabolic Diseases Advisory Committee (GeMDAC)

Environmental Monitoring in Compounding

Environmental Monitoring in Compounding

Module 8 – Part 6: Artificial Intelligence (AI) & Machine Learning (ML) in MIDD

Module 8 – Part 6: Artificial Intelligence (AI) & Machine Learning (ML) in MIDD

Module 8 – Part 5: Real-World Data (RWD) & Real-World Evidence (RWE)

Module 8 – Part 5: Real-World Data (RWD) & Real-World Evidence (RWE)

Module 8 – Part 4: Proposed Frameworks for Digital Health

Module 8 – Part 4: Proposed Frameworks for Digital Health

Module 8 – Part 3: Patient Centricity

Module 8 – Part 3: Patient Centricity

Module 8 – Part 2: FDA Feedback on DHT- based COA Submissions

Module 8 – Part 2: FDA Feedback on DHT- based COA Submissions

Module 8 – Part 1: Introduction to Digital Health

Module 8 – Part 1: Introduction to Digital Health

Module 7 – Case Study 7: QSP Modeling to Predict Safety & Efficacy

Module 7 – Case Study 7: QSP Modeling to Predict Safety & Efficacy

Module 7 – Case Study 6: Caplacizumab Model-Based Dosing Recommendations in Pediatrics

Module 7 – Case Study 6: Caplacizumab Model-Based Dosing Recommendations in Pediatrics

Module 7 – Case Study 5: Application of PBPK Models in Eliglustat Clinical Development

Module 7 – Case Study 5: Application of PBPK Models in Eliglustat Clinical Development

Module 7 – Case Study 4: MIDD to Establish Isatuximab Combination Dosing Regimen

Module 7 – Case Study 4: MIDD to Establish Isatuximab Combination Dosing Regimen

Module 7 – Case Study 3: Acceleration of Phase 2 Study through the MIDD Pilot Program

Module 7 – Case Study 3: Acceleration of Phase 2 Study through the MIDD Pilot Program

Module 7 – Case Study 2: Model-Informed Clinical Development of Mosunetuzumab

Module 7 – Case Study 2: Model-Informed Clinical Development of Mosunetuzumab

Module 7 – Case Study 1: Optimizing CERA Pediatric Drug Development

Module 7 – Case Study 1: Optimizing CERA Pediatric Drug Development

Module 6 – Applying MIDD Strategies to Decision-Making

Module 6 – Applying MIDD Strategies to Decision-Making

Module 5 – Why Use Models to Inform Decisions?

Module 5 – Why Use Models to Inform Decisions?

Module 4 - Case Study 6: Role of Modeling & Simulation in the Development of Pembrolizumab

Module 4 - Case Study 6: Role of Modeling & Simulation in the Development of Pembrolizumab

Module 4 – Case Study 5 Pharmacometrics & QSP-Based Analysis to Guide GnRH Receptor Modulator Dev’t.

Module 4 – Case Study 5 Pharmacometrics & QSP-Based Analysis to Guide GnRH Receptor Modulator Dev’t.

Module 4 – Case Study 4: Vaccine PKPD, MBMA, and Beyond

Module 4 – Case Study 4: Vaccine PKPD, MBMA, and Beyond

Module 4 Case Study 3 Pediatric Drug Development, Utilization of Top-Down and Bottom-Up Approaches

Module 4 Case Study 3 Pediatric Drug Development, Utilization of Top-Down and Bottom-Up Approaches

MIDD Training Module 4 – Case Study 2: Anti-Viral Kinetic Modeling

MIDD Training Module 4 – Case Study 2: Anti-Viral Kinetic Modeling

MIDD Training Module 4 – Case Study 1: Decision Analysis to Support Drug Development

MIDD Training Module 4 – Case Study 1: Decision Analysis to Support Drug Development

MIDD Training Module 4 – Foundation to Model Informed Drug Development and Model Interconnectedness

MIDD Training Module 4 – Foundation to Model Informed Drug Development and Model Interconnectedness

MIDD Training Module 3 – Impact and Decision-Making

MIDD Training Module 3 – Impact and Decision-Making

MIDD Training Module 3 – Pediatric Drug Development Considerations

MIDD Training Module 3 – Pediatric Drug Development Considerations

MIDD Training Module 2 – Part Two

MIDD Training Module 2 – Part Two

MIDD Training Module 2 – Part One

MIDD Training Module 2 – Part One

MIDD Training Module 1

MIDD Training Module 1

MIDD Training OVERVIEW

MIDD Training OVERVIEW

Introduction to the MIDD Training Course

Introduction to the MIDD Training Course

OSIS Workshop: CDER BA/BE Study Sites and Inspections of Good Laboratory Practice

OSIS Workshop: CDER BA/BE Study Sites and Inspections of Good Laboratory Practice

ICH Q12: What Industry Needs to Know – Pharmaceutical Quality Symposium 2023

ICH Q12: What Industry Needs to Know – Pharmaceutical Quality Symposium 2023

Introduction to FDA’s Office of Trade and Global Partnerships

Introduction to FDA’s Office of Trade and Global Partnerships

Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule

Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration

Improving the Sterility Assurance Application to the FDA – Generic Drugs Forum (GDF) 2024

Improving the Sterility Assurance Application to the FDA – Generic Drugs Forum (GDF) 2024

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 4

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 4

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 3

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 3

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 2

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 2

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 1

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 1

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 1, Pt 4

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 1, Pt 4