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.
Over the past week, the FDA issued a final rule on BLAs and master files. Final Guidance was issued on charging for investigational drugs under an IND. Draft guidance was issued on use of data monitoring committees. Product specific guidances were published. The agency also announced continuation of its site visit training program for its regulatory project managers, extended the comment period for the draft guidance on master protocols for drug and biological product development and amended a request for nominations for voting members for the Genetic Metabolic Diseases advisory committee. Read More
The Dayton Chamber of Commerce doesn’t represent any of the pharmaceutical giants affected by the drug negotiation provision of the Inflation Reduction Act (IRA), HHS says in its motion to dismiss the complaint, nor does the Chamber’s geographically limited purpose connect it to the issue. Read More
The FDA has issued final guidance on charging for investigational new drugs in clinical trials, offering a minor update to its recommendations. In addition, the agency has published new draft and revised product-specific guidances and extended the comment period for its guidance on trial master protocols. Read More
The presentation and accuracy of medical information through traditional and social media — and even the headlines that accompany it — directly impact the nation’s health, FDA Commissioner Robert Califf told a gathering of reporters Wednesday in Washington, D.C. Read More
With the composition, practice and utilization of data monitoring committees (DMC) changing considerably over the years, the FDA has published a new draft guidance on their use in clinical trials that will modernize its advice on the subject. Read More
FTC and HHS are jointly seeking more intel on how the practices of two types of pharmaceutical drug middlemen — group purchasing organizations (GPOs) and drug wholesalers — may be contributing to generic drug shortages. Read More
Two online marketers of semaglutide (Wegovy/Ozempic) and tirzepatide (Mounjaro) received FDA warning letters for selling the unapproved, untested drugs to consumers through their websites. Read More
A federal judge in Texas has handed the Biden administration a win in its quest to control Medicare drug pricing, dismissing a lawsuit that challenged the legality of negotiating Medicare drug prices as required by the Inflation Reduction Act (IRA). Read More
The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) pathway would be restrictive to manufacturers in the cell and gene therapy spaces, the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy said in filed comments. Read More