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PhRMA has asked the U.S. Supreme Court to grant petitions from the Department of Justice (DOJ) and Danco Laboratories and reverse the U.S. Court of Appeals for the Fifth Circuit judgment on Mileprex (mifepristone) because it “sets a precedent that — if left undisturbed — could significantly disrupt industry and stifle innovation in drug development.” Read More
Manufacturers of drugs and medical devices make several common errors when choosing the sample size for their sampling plan, but selecting too few samples routinely tops the list, according to Steven Walfish, president of Statistical Outsourcing Services. Read More
Over the past week, the FDA issued final guidances on assessment of tissue containment systems, testing and labeling medical devices for safety in the magnetic resonance environment and draft guidance on quality considerations for topical ophthalmic drug products. Read More
Sponsors of postmarket trials and certain phase 3 trials can now expect the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to process their trial applications within two weeks rather than the statutory 30 days, as long as they meet certain criteria. Read More
Companies manufacturing drug-device combination products must determine whether the benefits associated with each constituent part and the overall product outweigh the risks, says Susan Neadle, president of Combination Products Consulting Services. Read More
Alvotech announced Thursday that the FDA has issued a complete response letter (CRL) for the company’s BLA for AVT04, a biosimilar candidate to Stelara (ustekinumab), for deficiencies found during a March FDA inspection of its manufacturing facility. Read More
The FDA’s newest draft guidance discusses quality considerations for ophthalmic drugs, including ways to assess impurities, evaluate visible contaminants, design containers and conduct stability studies. Read More
The burden is on companies to convince health regulators that an effective quality management maturity (QMM) program is built into its governance structure, according to a pair of Merck executives who spoke at WCG Clinical’s virtual Good Manufacturing Practice (GMP) Quality vSummit Wednesday. Read More
Establishing greater industry agility in quality management requires increased technical harmonization and regulatory convergence among global health agencies, says Theresa Mullin, associate director for strategic initiatives with CDER. Read More
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on what to expect from the FDA in 2024, quality culture and how to use UDI and UDI Data. Read More