FDA Related News

Medical Devices

FTC Approves Final Valeant Order

FTC approves an order requiring Valeant Pharmaceuticals to sell Paragon Holdings and Pelican Products.

Human Drugs

Court Approves Regeneca Worldwide Consent Decree

A California federal court approves a consent order between FDA and dietary supplement distributor Regeneca Worldwide, prohibiting the company from se...

Human Drugs

FDA Clears Access Scientific 3 French IV Catheter

FDA clears an Access Scientific 510(k) for its new 3 French, 6cm Powerwand, an extended-dwell intravenous catheter designed for forearm and upper-arm ...

Human Drugs

Exela Pharma Recalls Ibuprofen Lysine Injection

Exela Pharma Sciences recalls one lot of ibuprofen lysine injection, 20mg/2mL (10mg/mL) because some vials have been found to contain particulate matt...

Human Drugs

Acorda Therapeutics NDA for Parkinsons Therapy Planned for 2Q

Acorda Therapeutics says it will file an NDA next quarter for Parkinsons therapy CVT-301 after reporting Phase 3 clinical data that showed a statistic...

Human Drugs

FDA, Armetheon Agree on Phase 2 Trial for Anticoagulate

FDA and Armetheon reach agreement for a single 1,000-patient final pivotal trial for its drug candidate, tecarfarin prior to filing an NDA

Stakeholders Ask Intended Use Rule Stay and Reconsideration

Major regulated industry stakeholders petition FDA for an indefinite stay of its 1/9 final rule on intended use and reconsideration of the definition.

Human Drugs

FDA Approves Emflaza Duchenne Drug

FDA approves Marathons Emflaza, a corticosteroid, for treating Duchenne muscular dystrophy in patients age 5 and older.

FDA General

FDA Commissioner Due to be Named?

Politico reports that President Trump may soon nominate either Jim ONeill or Scott Gottlieb to be commissioner of FDA.

Human Drugs

Model BE Data Summary Tables Updated

FDA makes minor revisions to its Model Bioequivalence Data Summary Tables