FDA Related News

Human Drugs

Concerns About Opioid Mail-Back Envelope Proposal

Two drug stakeholder associations ask FDA to reconsider its proposal that opioid manufacturers provide mail-back envelopes to use in disposing of opio...

Medical Devices

BD Recalls Intraosseous Products

BD says it is recalling intraosseous products that have several issues.

Human Drugs

Merarini Files NDA for Breast Cancer Therapy

The Menarini Group submits an NDA for elacestrant and its use in patients with ER+/HER2 advanced or metastatic breast cancer.

Biologics

Updated CBER Guidance Agenda

CBER updates its guidance agenda for 2022 containing 18 guidances it plans to develop.

Biologics

Krystal Biotech BLA for Topical Gene Therapy

Krystal Biotech files a BLA for B-Vec (beremagene geperpavec), a topical gene therapy for treating patients with dystrophic epidermolysis bullosa.

Human Drugs

Florida Man Arrested in HIV Drug Distribution Scheme

The U.S. government arrests Lazaro Hernandez of Miami, FL, for allegedly distributing over $230 million in adulterated HIV drugs.

Human Drugs

Converted OTC Products are Not Listed Drugs: FDA

Attorney Michael Shumsky explains how a previously unknown FDA administrative change can allow NDA holders to gut the 180-day exclusivity incentive fo...

Human Drugs

Mexican Firm Refuses FDA Inspection

FDA warns Mexicos Glicerinas Industriales that its drug products are adulterated because the company refused to allow an FDA inspection.

Appeals Court Upholds WV Law on Misleading Lawyer Ads

Two Shook, Hardy attorneys say the 4th Circuit Court of Appeals has upheld a West Virginia law restricting ways in which plaintiff attorneys can adver...