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Human Drugs

Amryt Seeking Dispute Resolution on Filsuvez NDA

Amryt seeks FDA formal dispute resolution over a complete response letter it received in February for its NDA for Filsuvez (oleogel-S10), indicated fo...

Human Drugs

Ex-Pharmatech CEO Pleads Guilty to Defrauding FDA

Former Pharmatech CEO Raidel Figueroa pleads guilty to conspiring to defraud FDA, among other charges, in a case involving contaminated drug products.

Human Drugs

Alternate e-Format Guide for Drugs/Biologics

FDA makes available a guidance entitled Providing Regulatory Submissions in Alternate Electronic Format.

Medical Devices

Blood-Brain Barrier Disruptor Device Gets Breakthrough

FDA grants Carthera a breakthrough device designation for its SonoCloud-9 system, a device that uses low intensity pulsed ultrasound to temporarily di...

Federal Register

Info Collection on Human Subject Protection

Federal Register notice: FDA seeks comments on an information collection extension entitled Protection of Human Subjects; Informed Consent; and Instit...

Federal Register

Guide on Rescinding Breakthrough Therapy Designations

Federal Register notice: FDA makes available a draft guidance entitled Considerations for Rescinding Breakthrough Therapy Designation.

Federal Register

Drug GMP Guide on Preventing Cross-Contamination

Federal Register notice: FDA makes available a draft guidance entitled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contami...

Federal Register

Guide on Food Effect Clin-Pharm Considerations

Federal Register notice: FDA makes available a final guidance entitled Assessing the Effects of Food on Drugs in INDs and NDAs Clinical Pharmacology ...

Human Drugs

Guide on Oligonucleotide Therapeutic Development

FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.

Human Drugs

AbbVie sNDA for Qulipta to Prevent Chronic Migraine

AbbVie submits an sNDA for Qulipta as a preventive treatment for chronic migraine.