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New digital technologies that enable clinical trials to take place in locations other than traditional trial sites are the subject of a long-awaited FDA draft guidance on conducting decentralized trials (DCT). Read More
A group of 26 state attorneys general joined the outcry against Medicare’s ongoing payment restrictions on antiamyloid antibody Alzheimer’s therapeutics, sending a letter to HHS last week calling for full coverage of the drugs. Read More
The FDA outlined its latest thinking on developing nicotine replacement therapy (NRT) drugs in a final guidance released Monday, including detailed recommendations for clinical trials to support product applications. Read More
The FDA’s ability to function is threatened by the loss of public respect for the agency’s science-based decision making, which is “arguably at an all-time low,” said Steven Grossman, executive director of the Alliance for a Stronger FDA. Read More
The European Medicines Agency’s (EMA) human medicines committee has signed off on GSK’s Arexvy (recombinant, adjuvanted), the first respiratory syncytial virus (RSV) vaccine for adults age 60 years and older as well as six other new drugs at its latest monthly meeting. Read More
Starting in September, the European Medicines Agency (EMA) will begin gradually resuming its efforts to openly share clinical trial data for medical products, the agency reported. Read More
The investigational drug phase 1 single-ascending dose portion initial data will no longer be reported in the second half of 2023, the company said. Read More
On Wednesday, the EU released the long-anticipated, wide-ranging revision of its drug development legislation, proposing changes that would affect nearly every part of drug development and authorization and raising opposition in the pharmaceutical industry. Read More
Twenty-four U.S. Senators have sponsored legislation that would begin the Medicare drug price negotiation enacted in the Inflation Reduction Act (IRA) sooner and increase the number of drugs included in price negotiations. Read More
Four years after passing a state law to begin importing less pricey drugs from Canada, Florida has just filed its second lawsuit accusing the FDA of delaying authorization of the program. Read More
Though the U.S. Supreme Court has for now preserved the status quo for access to the abortion pill mifepristone, a bevy of amicus briefs filed with the court provides a glimpse into the looming fight not just over the nature of the drug itself, but of the downstream effect any decision may have on the authority and operations of the FDA. Read More