The FDA issued a complete response letter (CRL) for Sanofi and Regeneron’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) in chronic spontaneous urticaria (CSU) requesting additional efficacy data, the companies…
The FDA, Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly published guiding principles that lay the foundation for predetermined change control plans (PCCP) for…
Though there is no regulation requiring they do so, companies that receive an FDA Form 483 should always provide a response in writing that is well-organized, comprehensive and includes adequate…
While it might seem obvious, achieving effective corrective and preventive action (CAPA) plans requires diligence and consistent application of three core elements. Source: Drug Industry Daily
With one in four medical devices incorporating some form of medical device software (MDSW), the European Council’s Medical Device Coordination Group (MDCG) has issued a guidance on the regulatory pathway…
Panacea Biotec, a maker of generic and specialty pharmaceuticals as well as vaccines, got rapped with a nine-observation Form 483 for inadequate oversight of aseptic procedures and environmental conditions for…
The proposed regulation to curb ethylene oxide (EtO) emissions would bring some surgeries and other medical procedures to a screeching halt, a medical device industry representative told a congressional subcommittee…
The FDA has issued a draft guidance intended to strike a balance between health care providers’ interest in scientific information on unapproved uses of approved/cleared medical products and mitigating the…
In this edition of Quick Notes, we cover another Philips ventilator recall, GE HealthCare and Novo Nordisk collaborate to develop a diabetes and obesity ultrasound treatment and 510(k) clearance for…
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…