We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Drugmakers won a victory on Monday when the Senate approved by unanimous consent an amended bill that would extend exclusivity periods for new drugs by changing the date on which they are considered to have been approved from FDA sign-off to when the DEA schedules them. Read More
The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that the drug bound to about half of the oral medications tested. Read More
The FDA should establish searchable names and correct incomplete entries in its inactive ingredient database to enhance its accuracy and usability, generic drug and excipients makers say. Read More
The FDA could issue guidance on demonstrating interchangeability between a biosimilar and its reference product by the end of the first quarter of next year. Read More
Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More
In a conflicted decision with most members suggesting postmarketing studies, an FDA advisory panel voted 10 to four Friday to recommend approval of AstraZeneca’s gout drug lesinurad. Read More
FDA’s Office of Manufacturing Quality will now be involved in evaluating all BLAs and supplements to ensure product quality throughout a product’s lifecycle. Read More