Legislative Update — Week of April 24, 2023
As the 118th Congress continues, FDAnews will be tracking the important pieces of pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily
Supreme Court Sends Mifepristone Ruling Back to Appeals Court for Arguments in May
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…
FDA Seeks Comments on Proposed Consumer Rx Advertising Survey
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…
FDA and FTC Focus on Enforcement of Connected Medical Devices
Makers of connected medical devices should brace themselves for more FDA enforcement — warning letters, inspections, demands for information and untitled letters — as the digital health space unfolds and…
Bluebird Amps Up Lovo-Cel’s Regulatory Package With BLA, Priority Review Request
Bluebird Bio is pulling out all the regulatory stops for its investigational sickle cell disease (SCD) gene therapy lovotibeglogene autotemcel (lovo-cel), submitting a BLA with a request for priority review…
Avanos Medical’s Ballard Access Ventilation Device Recall Labeled Class I
The FDA has deemed Avanos Medical’s Feb. 22 recall of certain Ballard Access closed suction ventilation devices as Class I, the most serious type of recall, as using these devices…
FDA Program Profile: STeP Program Speeds Technology to Market
The latest devicemaker to follow an important FDA pathway for technological innovation in devices is French company UroMems, which has snagged a Safer Technologies Program (STeP) designation for its UroActive…
EMA Adopts Final ICH S12 Covering Nonclinical BD Studies for Gene Therapies
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…
More Than Half of Medicare’s Popular Drugs Have Low Added Benefit, Study Shows
More than half of the best-selling brand-name drugs covered by Medicare may not provide significant added therapeutic benefits despite comprising a large portion of the federal agency’s spending, according to…
Moderna, IBM Team Up to Accelerate mRNA Research With Quantum Computing, AI
mRNA developer Moderna and computer giant IBM have announced an agreement under which Moderna will explore next-generation technologies, including quantum computing and artificial intelligence (AI), to accelerate mRNA research and…
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