Inadequate responses to the findings of an October 2023 FDA inspection of Royal Philips’ Suzhou, China, facility has earned the company a Warning Letter citing the risks of malfunctioning of…
Most postmarketing requirements (PMR) and postmarketing commitments (PMC) for NDAs and BLAs were on-schedule in 2022, according to figures just released by the FDA. Source: Drug Industry Daily
Answers to questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars have been issued by the FDA in a revised…
Peter Marks, director of CBER, is pushing to get more gene therapies targeting rare diseases to apply for accelerated approval (AA) to give the promising space a leg up in…
With an aim of supporting patients, medical device developers and policymakers, the CDRH has launched a new initiative to deliver virtual reality-enabled models for use in the development of home-based…
Almost 60 percent of surrogate markers supporting FDA approvals for nononcologic drugs for chronic diseases aren’t backed up by meta-analyses showing a strong association between the marker and relevant clinical…
Identifying and reducing production and delivery vulnerabilities are the focus of the European Medicines Agency’s (EMA) recent recommendations to ensure the availability of medicines identified as critical. Source: Drug Industry…
Exactech has initiated a recall to remove Equinoxe shoulder system devices packaged in defective bags from facilities’ unused inventory the FDA announced in an update of its Jan. 16 safety…
Two pharmaceutical giants based in Japan — Takeda and Astellas — have signed a master agreement along with Sumitomo Mitsui Banking Corporation to establish a joint venture company dedicated to…
Allergan must still face allegations that it violated the False Claims Act by incentivizing physicians to prescribe off-label Botox for pediatric migraine, although a federal circuit court judge dismissed charges…