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The FDA’s newest draft guidance discusses quality considerations for ophthalmic drugs, including ways to assess impurities, evaluate visible contaminants, design containers and conduct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…
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. Source: Drug…
Abiomed received a warning letter for its Impella Connect System for failing to have an approved application for premarket approval or an investigational device exemption, according to the FDA’s warning…
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…
The FDA has created the new Digital Health Advisory Committee to help the agency explore the complex issues related to artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics,…