Topic:

Regulatory

Latest Headlines

Latest Headlines

Sage takes to the FDA fast track with its lead rare disease drug

Fresh off grossing $103.5 million in an overstuffed IPO, Cambridge, MA's Sage Therapeutics has secured the promise of a speedy FDA review for its top prospect, a treatment for a rare seizure disorder.

FDA again warns that Texas compounder's products may not be sterile

The FDA continues its battle with a Dallax, TX compounding pharmacy which it says is not meeting sterility standards.

FDA approves expandable implant for spinal fusion surgery

The FDA has cleared Expanding Orthopedics's FLXfit implant for spinal fusion surgery, the Israeli company announced July 21. 

FDA clears Varian soft tissue transponder to treat cancer

Varian Medical Systems scored FDA 510(k) clearance for its soft tissue transponder for radiotherapy and radiosurgery treatments.

Patient groups argue for faster med tech FDA approvals at industry meeting

The president of the Society for Cardiovascular Angiography and founder of the Children with Diabetes Foundation made their case for faster approvals at a July 17 AdvaMed hearing in Washington, DC. 

Animal health companies not exempt from FDA marketing regs, either

The FDA issued Paris-based AB Science a warning letter regarding its Kinavet-CA1 canine drug, intended for mast cell tumors in dogs, for allegedly boasting its off-label uses without approval.

J&J partner Aduro grabs an FDA 'breakthrough' nod for its immuno-oncology combo

Aduro BioTech joined the short list companies outside Big Pharma to pick up the FDA's coveted breakthrough therapy designation, impressing the agency with strong mid-stage results for its combo cancer therapy.

Seizures in horses in Kentucky focus attention on drug compounding

Former FDA associate commissioner Peter J. Pitts added his voice to calls for the need to regulate animal drug compounders who put together illegal animal drug combos, accusing the FDA of doing nothing while animals are dying from the practice.

FDA adds recalls API as openFDA initiative gathers pace

The FDA is continuing to push ahead with its openFDA initiative, with this week's rollout of an application programming interface (API) for recall data coming a month after its adverse event system went live. And the regulator plans to maintain the pace throughout the rest of the summer.

Top officials at FDA's India office bolt after less than a year

FDA Commissioner Margaret Hamburg has urged India's drugmakers and regulators to get on board with international quality standards, while promising close cooperation from its expanded office there. But efforts are being hampered by the exit of top officials.