Tag:
FDA
Latest Headlines
Latest Headlines
FDA taps India's GVK for database support in drug recycling
The FDA has hit the gas on efforts to discover new uses for existing drugs, and Hyderabad, India-based GVK Biosciences has licensed a database to the U.S. agency that includes loads of SAR, pharmacokinetic and toxicity information.
Novo Nordisk's R&D chief sizes up diabetes rivals and scandal-wary FDA
Novo Nordisk has begun to regroup after the FDA denied approval of its blockbuster hopeful, Tresiba, seeking cardiovascular outcomes data on the long-acting insulin that will delay the U.S. launch of the drug by several years. Read more >>
UPDATED: Idenix plunges after FDA throws up a roadblock for lead hep C 'nuc'
The FDA has hit the biotech group with a request for more preclinical data on IDX20963, which is Idenix's lead drug in the closely watched class of uridine nucleotide prodrugs, sometimes called "nucs" for short.
FDA joins chorus of concern about cybersecurity threats
The FDA jumped off the sidelines in the ongoing discussion about threats to networked medical devices, issuing draft guidance to manufacturers and others to take additional precautions against cyberattacks that endanger patients.
FDA wants tighter cybersecurity for medical devices
As concerns about the hackability of medical devices mount around the world, the FDA is proposing tighter regulations for manufacturers, suggesting that companies include cybersecurity information along with clinical data when seeking approval.
Study: Medical devices spur complications for kids
Children with complex conditions often must rely on medical devices to survive, but, because most are designed for adults, life-saving technologies can also expose kids to additional risks, according to a study.
UPDATED: FDA advisers vote for looser reins on GlaxoSmithKline's Avandia
It took multiple tries and a vote tallied on paper to make sure everything was correct, but finally, we have a verdict. After two days of hearings, on Thursday an advisory panel recommended the FDA keep Avandia on the market and ease restrictions on its use.
Australia packager gets FDA warning letter
A warning letter has been issued to Contract Pharmaceutical Services of Australia, which does drug packaging at a plant in the Sydney suburb of New Ryde.
FDA official, panelists challenge Avandia safety trial
Dr. Thomas Marciniak, medical team leader of FDA's Division of Cardiovascular and Renal Products, made some expensive promises Wednesday morning before a panel of outside experts tasked with advising the FDA on whether to lift current restrictions on GlaxoSmithKline's diabetes drug Avandia.
FDA issues warning letter for Novartis Ebewe plant
Any drug manufacturer that fails to take instructions from FDA is inviting trouble, and that is what Novartis got by releasing products from a Sandoz Ebewe plant after the agency said they had been manufactured using unapproved inspection procedures.
