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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 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. Read More
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 give devicemakers a way to get the FDA’s help with quality measures that go beyond regulatory compliance. 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The FDA’s newest draft guidance discusses quality considerations for ophthalmic drugs, including ways to assess impurities, evaluate visible contaminants, design containers and conduct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
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 letter. 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
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, wearables, remote patient monitoring and software as well as decentralized trials, patient-generated health data and cybersecurity. Read More
Most predictive clinical decision support devices (CDS) that rely on machine learning (ML) or AI are approved and marketed without adequate proof that they deliver on their promise of improving outcomes for patients with critical illnesses, a study has found. Read More