The FDA questioned and answered virtually all aspects of Remote Regulatory Assessments (RRA) in an 18-page revised draft guidance issued last January, and the comments on the Q&A document have…
This edition of Quick Notes reviews the regulatory and/or judicial status of four drugs, including an add-on therapy for a rare blood disorder, a drug to treat forms of pulmonary…
Guest columnists Darius Lakdawalla and Charles Phelps write on the need for a new way to evaluate the value of drugs and therapies. Darius Lakdawalla is the Quintiles Chair in Pharmaceutical…
A corporate culture that values quality management at every level is key to achieving and maintaining high-quality data throughout the life cycle of all in vivo bioavailability (BA) and bioequivalence…
New draft guidance for ceramic and metal coatings on implantable orthopedic devices needs to recognize the different bonding characteristics of a new generation of extremely thin, nonporous metallic coatings applied…
Can remote cognitive testing via smartphones yield reliable and valid data to evaluate people for a type of dementia? Findings of a study of 360 individuals spanning over four and…
Two newly revised FDA policy papers outline how CDER will evaluate Risk Evaluation and Mediation Strategies (REMS) and REMS Assessment Reports. Source: Drug Industry Daily
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…
Three FDA final guidances address electronic submissions for reporting adverse reactions — one for investigational new drug application (IND) safety reports, one for transmitting electronic individual case safety reports (ICSR),…
The FDA is providing a public list of all approved ANDAs for drugs that received a Competitive Generic Therapy (CGT) designation and will note which ANDAs are for drugs that…