FDA Related News

Human Drugs

Multiple Violations at Contract Manufacturer

FDA warns Torrance, CA-based Cosmetic Science Laboratories about CGMP and other violations in its production of finished drugs as a contract manufactu...

Turn Gene Therapy into Reality: Marks

CBER director Peter Marks tells a Muscular Dystrophy Association conference about ways FDA is addressing barriers to developing gene therapies for rar...

CDERs Requests for Intarcia Hearing

CDER submits a petition outlining its requests if the FDA chief scientist decides to grant Intarcia a hearing on its NDA for drug/device combination I...

Federal Register

Guide on Pharmacogenomic Data Submissions

Federal Register notice: FDA makes available a draft guidance entitled Pharmacogenomic Data Submissions.

Medical Devices

CDRH Modifies Electronic 510(k) Portal

CDRH adds more functionality to its medical device electronic submission portal to prepare for an all-electronic submission process.

Federal Register

Acufocus IOL Regulatory Review Period

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for AcuFocus IC8 apthera intraocular lens.

Federal Register

Regulatory Review Period for Jivi

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bayers hemophilia A therapy Jivi.

Human Drugs

FDA Input on Rare Disease Development Needed: PhRMA

Pharmaceutical Research and Manufacturers of America urges FDA to provide more input on the types of evidence that may be considered in rare disease d...

Medical Devices

Keep Device Real-World Evidence Under NESTcc: MDMA

Medical Device Manufacturers Association says it would be wasteful and duplicative to use medical device user fee funds to advance real-world data/evi...

Human Drugs

Athenex Cell Therapy on Clinical Hold

FDA issues a clinical hold against Athenex and Baylor College of Medicines kUR-501 after the death of a young heavily pretreated male patient.