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May 15, 2020

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

On May 14, 2020, the Food and Drug Administration expanded the indication of pomalidomide (POMALYST, Celgene Corporation) to include treating adult patients with AIDS-related Kaposi sarcoma […]
May 15, 2020

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry

Docket Number: FDA-2018-D-1609 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The concepts outlined in prior ICH Quality Guidelines (ICH Q8, Q9, Q10 […]
May 15, 2020

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex

Docket Number: FDA-2018-D-1609 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research At Step 2 of the ICH Process, a consensus draft text or […]
May 15, 2020

Q11 Development and Manufacture of Drug Substances–Questions and Answers (Chemical Entities and Biotechnological/Biological Entities)

Docket Number: FDA-2011-D-0436 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Since the ICH guidance Q11 Development […]
May 15, 2020

Q11 Development and Manufacture of Drug Substances

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes approaches to developing and understanding the […]
May 15, 2020

Principles of Premarket Pathways for Combination Products

Docket Number: FDA-2019-D-0078 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products Center for Drug Evaluation […]
May 15, 2020

Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Docket Number: FDA-2016-D-0269 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance sets forth the FDA’s policy concerning certain prescription requirements for […]
May 15, 2020

Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry

Docket Number: 2019-22690 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations to applicants […]
May 15, 2020

Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials

Docket Number: FDA-2018-D-1201 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations about how […]
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