FDA Related News

Federal Register

Joint Panel to Review Janssen Spray for Depression

Federal Register notice: FDA announces a joint 2/12 advisory committee meeting to review a Janssen Pharmaceuticals NDA for depression.

Human Drugs

Stakeholders Suggest Q12 Changes

Stakeholders suggest revisions to an ICH draft guidance on pharmaceutical product lifecycle management technical and regulatory considerations.

Human Drugs

Real-World Evidence Framework is Good Foundation: Merck

Stakeholders say FDA has done a good job in developing a framework for using real-world evidence to support some drug approvals and post-approval stud...

Human Drugs

Comments on FDA Rare Diseases Draft Guidance

Stakeholders suggest improvements to a draft FDA guidance on early drug development for rare diseases and the role of pre-IND meetings.

Human Drugs

FDA Approves Ablynx Drug for Rare Blood Clotting

FDA approves a Ablynx BLA for Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and...

Combination Product Pathway Guidance

FDA releases a draft guidance on principles for premarket review of combination products, including determining the appropriate type of premarket subn...

Federal Register

Vaccines and Related Biological Products Advisory Committee Meeting

Federal Register notice: FDA announces a 3/6-7 Vaccines and Related Biological Products Advisory Committee meeting.

Human Drugs

FDA Gains Consent Decree Against Drug Operation

A federal court in western Pennsylvania enters a consent decree against Raniers Rx Laboratory (doing business as Raniers Compounding Laboratory) in Je...

Human Drugs

CGMP Violations at Hangzhou Zhongbo

FDA warns Chinas Hangzhou Zhongbo about repeated CGMP violations in its production of finished pharmaceuticals.

Human Drugs

Pain Therapeutics Blasts FDA After Remoxy Meeting

Pain Therapeutics blasts FDA for its review of the companys Remoxy opioid.