As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and…

Understanding FDA quality system requirements may be more confusing under the new Quality Management System Regulation (QMSR) due to be finalized in December, says one regulatory expert, but actual compliance…

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tissue containment systems, testing and labeling medical devices for safety in the magnetic resonance environment and draft guidance…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