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March 1, 2022

Pediatric Tracking Requirements Under FDAAA

The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant […]
March 1, 2022

Sleep Disorder (Sedative-Hypnotic) Drug Information

Sedative-hypnotic drug products are a class of drugs used to induce and/or maintain sleep. FDA Drug Safety Communications: Prescription Insomnia Drugs (UPDATED) For prescribing information, please […]
March 1, 2022

FDA approves drug for adults with rare form of bone marrow disorder

Action FDA has granted accelerated approval for Vonjo (pacritinib) capsules to treat adults who have a rare form of a bone marrow disorder known as intermediate […]
March 1, 2022

Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

Docket Number: FDA-2018-D-3292 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance […]
March 1, 2022

Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

Docket Number: FDA-2018-D-2777 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence The purpose […]
February 28, 2022

FDA warns that vapors from alcohol-based hand sanitizers can have side effects

Listen Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. On June 16, 2021, FDA warned that symptoms […]
February 28, 2022

Sharing Experiences in Rare Diseases Together

Image By: Janet Woodcock, M.D., Principal Deputy Commissioner, and Sandra Retzky, D.O., J.D., MPH, Director, Office of Orphan Products Development, Office of Clinical Policy and Programs  […]
February 25, 2022

Prescription Drug Marketing Act of 1987

The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President on April 22, 1988. The PDMA was enacted (1) to ensure […]
February 25, 2022

S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

Docket Number: FDA-2009-D-0573 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Note: In June 2011, the […]
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