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.
A comprehensive readiness plan for an FDA inspection includes thorough knowledge of your document archiving and transfer procedures, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
The FDA is not extending its enforcement discretion policy for Investigational New Drug (IND) requirements governing the use of fecal microbiota for transplantation (FMT) obtained from stool banks for treatment of C. difficile infection that is not responding to standard therapy, the agency said in a final guidance released yesterday. Read More
Included in — then stripped out of — user fee legislation in September were requirements that the FDA and drug manufacturers agree on post-approval study conditions prior to a drug’s accelerated approval (AA) and require more regular study progress updates from manufacturers. The proposals also sought to permit the FDA to require studies to be underway at the time the drug is approved, or prior to that time, and to allow use of real-world evidence to support the studies. Read More
Accelerated approval (AA) was catapulted directly into the public eye with the FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) 18 months ago on the shaky success of its surrogate endpoints — and the pathway has stayed firmly in the limelight ever since, facing increasing scrutiny from seemingly all quarters. Read More
The FDA has issued a warning letter to a Lake Forest, Calif.-based biologics company, Invitrx Therapeutics, for selling unapproved allogenic cellular-derived drugs, including a human umbilical cord-derived product. Read More
Three union pension funds have filed a class action antitrust suit against Bristol Myers Squibb (BMS) and several generic drugmakers claiming the companies conspired to restrict competition on blockbuster blood cancer drug Revlimid (lenalidomide) and share in the profits, thus creating a monopoly. Read More
Newly proposed bipartisan legislation would require the Drug Enforcement Administration (DEA) to reclassify psilocybin and MDMA (“Ecstasy”) from Schedule I to Schedule II drugs, relaxing some of the federal laws that have so far complicated research on strictly controlled psychoactive drugs. Read More
Two years after its blood cancer treatment Blenrep (belantamab mafodotin) won accelerated approval from the FDA, GSK has removed the drug from the market in the U.S. at the FDA’s request. Read More