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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The FDA’s newest draft guidance discusses quality considerations for ophthalmic drugs, including ways to assess impurities, evaluate visible contaminants, design containers and conduct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
A district court has handed a preliminary injunction to EOFlow, blocking it from selling products developed using proprietary information derived from insulin pump maker Insulet — the decision arriving as Medtronic is slated to pay $738 million to acquire EOFlow. Read More
Guidance updates, Novo Nordisk complaint against semaglutide compounders tossed, and AdvaMed forms new digital tech division, in this edition of Quick Notes. Read More
Pfizer announced that the FDA has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab), giving pharmacists the ability to substitute it for Humira without intervention from the prescribing clinician. Read More