FDA Related News

Medical Devices

Suggestions for HDE Draft Guidance Changes

Four stakeholders give FDA input on a draft humanitarian device exemption guidance.

FDA Veterinary Medicine Opioid Resources

FDA issues new resources for veterinarians to help them understand opioid problems in the context of a veterinary practice.

Human Drugs

FDA Approves Expanded Use for Vertex Kalydeco

FDA approves Vertex Pharmaceuticals Kalydeco (ivacaftor) to include use in children with cystic fibrosis ages 12 to 24 months who have at least one mu...

Medical Devices

FDA Approves Grifols Zika Virus Assay

FDA approves Grifols Procleix Zika Virus assay for detecting the virus in individual or pooled plasma specimens from human donors.

Human Drugs

Westminster Pharmaceuticals Recalls Thyroid Drugs

Westminster Pharmaceuticals recalls all lots, within expiry, of its thyroid drugs levothyroxine and liothyronine because they were manufactured using ...

Federal Register

Joint Advisory Panel to Discuss Modernizing Drug Assessments

Federal Register notice: FDA announces a 9/20 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting that will discuss modernizin...

Human Drugs

CDERs Patrick Frey Leaving for Amgen

Office of New Drugs (OND) chief of staff Patrick Frey announces his departure to join Amgen as Global Regulatory Policy and R&D director.

Human Drugs

FDA, NIH Reducing Regulatory Oversight of Gene Therapy Trials

FDA and NIH propose to relax some oversight of gene therapy trials to help expedite product development.

Human Drugs

Comment Period Reopened on Animal Drug Impurities

Federal Register notice: FDA reopens the comment period on a draft guidance entitled Elemental Impurities in Animal Drug Products Questions and Answe...

Human Drugs

Joint FDA Panel Looks at Modernizing NDA Assessments

FDA announces a 9/20 advisory committee meeting to discuss modernizing its NDA assessments through a Knowledge-Aided Assessment and Structured Applica...