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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
The U.S. Supreme Court on Friday weighed in on the debate over access to the abortion pill mifepristone, permitting a stay sought by the Department of Justice earlier this month and adding a layer of complexity to an already tangled tale of drug approval and access. Read More
The FDA Office of Prescription Drug Promotion (OPDP) is seeking input on its proposal to conduct research into how consumers interpret certain quantitative information about prescription drugs often included in direct-to-consumer (DTC) advertising. Read More
The European Medicines Agency (EMA) has become the first regulator to accept the International Council for Harmonization (ICH) S12 guideline, laying out the council’s recommendations for how to conduct nonclinical biodistribution (BD) studies when developing gene therapy products. Read More
GenBioPro, the only U.S. maker of the generic version of the abortion pill mifepristone, has sued the FDA, HHS and DOJ in an effort to protect the company from regulatory action that could withdraw or limit FDA approval of its drug based on recent court rulings. Read More