FDA Related News

Human Drugs

Rare Disease Therapeutic Modalities Analyzed

Journal authors, including FDAers, analyze therapeutic modalities that could be used in developing new orphan drugs.

Human Drugs

Comments on Postmarketing Studies Draft Guidance

Stakeholders comment on an FDA draft guidance on postmarketing studies and clinical trials.

Human Drugs

Correvio Pharma NDA Again Rejected Over Safety Concerns

FDA again issues Correvio Pharma a complete response letter on its NDA for Brinavess (vernakalant IV), an anti-arrhythmic drug for converting atrial f...

Continue Kickback Protection for Drugs, Devices: WLF

Washington Legal Foundation calls on the HHS Inspector General to reverse its proposal to exclude drug and medical device manufacturers from proposed ...

Human Drugs

Eisai Insomnia Drug Approved by FDA

FDA approves an Eisai NDA for Dayvigo (lemborexant) 5 mg and 10 mg for treating adult patients with insomnia.

FDA Draft Bridging Guidance Out

FDA publishes a draft guidance recommending how to approach bridging in NDAs or BLAs for some drug-device and biologic-device combination products.

Human Drugs

Demonstrating Effectiveness Guidance for Drugs, Biologics

FDA issues a draft guidance to help applicants filing NDAs or BLAs or their supplements understand the evidence to be provided to demonstrate effectiv...

Human Drugs

FDA Drops Peptide Transition Exclusion

FDA says that allowing chemically synthesized peptides to use the biosimilar or interchangeable approval pathway will benefit consumers by bringing fo...

Human Drugs

FDA Approves Padcev for Urothelial Cancer

FDA approves Astellas Padcev, a new type of treatment for advanced urothelial cancer.

Human Drugs

FDA Using National Academies Report on Opioid Prescribing

FDA says it will use information in a National Academies report to work with medical professional societies on evidence-based guidelines for prescribi...