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…

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…

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tissue containment systems, testing and labeling medical devices for safety in the magnetic resonance environment and draft guidance…

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…

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…

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…

The European Commission (EC) is requiring DNA sequencing company Illumina to unwind its acquisition of liquid biopsy company Grail, an action mirroring the FTC’s April order to do the same.…

A top benefit of the Case for Quality Voluntary Improvement Program (VIP) for medical devices — a collaborative initiative formally recognized by the FDA in recent weeks — is to…

The FDA’s newest draft guidance discusses quality considerations for ophthalmic drugs, including ways to assess impurities, evaluate visible contaminants, design containers and conduct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. Source: Drug Industry Daily

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…