The FDA issued guidelines on its acceptance of medical device clinical data from overseas studies in a just-issued draft guidance, saying the "increasing globalization of clinical trials presents challenges to both US and foreign regulators."
Science is rapidly shaping the landscape of the diagnostics industry, from the research into genetics and new materials like graphene, to the regulatory science practiced at the FDA.
The FDA may be having difficulty getting inspectors stationed in China, but that has not stopped it from issuing warning letters to drug and ingredient makers there who have issues. The agency posted a second warning letter today for API maker Yunnan Hande Bio-Tech, which was previously cited in 2010.
The Wall Street Journal has caught up with the Genervon controversy, recapping a series of events from the last few days that followed the big social media campaign to gain an instant approval for a new ALS drug based on the results of a 12-patient study. FierceBiotech readers will know already that the data were questioned by Steve Perrin, president and chief scientific officer of the ALS Therapy Development Institute, and that the FDA followed up a day later with an extraordinary challenge to Genervon to publish the data on a drug that the biotech has touted as a major advance for patients.
To cap off one of the least effective seasons for flu vaccines in recent memory, vaccine producer GlaxoSmithKline announced the recall of all remaining doses of a quadrivalent, affecting roughly 1.7 million jabs.
Eli Lilly's closely watched autoimmune treatment ixekizumab met its main goals in a Phase III psoriatic arthritis trial, rolling toward an FDA application and a shot at competing in a fast-crowding space.
The FDA approved HyperBranch Medical Technology's Adherus AutoSpray Dural Sealant to provide watertight closure during cranial procedures, according to a March 30 approval letter. Approval came via the stringent PMA pathway, which included a clinical trial, after which Adherus was deemed noninferior to Integra LifeSciences' surgical sealant system.
Otsuka has already sued the FDA to block generic versions of the blockbuster antipsychotic Abilify, claiming that its orphan drug exclusivity on one indication should preclude copycat meds entirely.
The FDA said it's stepping up its efforts to address the shortage of saline solution for humans and animals by increasing the importation of intravenous fluids from producers not previously approved by the regulatory agency.
Johnson & Johnson's SGLT2 inhibitor Invokana (canagliflozin)--among a handful of drugs in the new category of DPP-4 drugs for diabetes--not only took a big jump in sales for the first quarter but also made some significant market-share gains.