An FDA advisory committee voted 13-0 yesterday in favor of the agency’s long-term strategy for its Knowledge-Aided Assessment and Structured Application (KASA) program, including expanding it from just generic drugs…
Sovereign Pharmaceuticals, a contract development and manufacturing organization (CDMO) based in Fort Worth, Texas, has received an FDA warning letter citing multiple quality control issues that led to inconsistent tablet…
AbbVie has filed a complaint against several generics producers — including Teva Pharmaceuticals and Novartis’ Sandoz unit — alleging the companies infringed on patents for its endometriosis drug Orilissa (elagolix)…
Sponsors should be prepared to discuss proposed labeling for combination oncology drug regimens with the FDA in pre-application meetings, the agency said in a final guidance released yesterday. Source: Drug…
The FDA handed Lupin Limited a warning letter citing the company’s failure to correct cross-contamination issues noted in an inspection of its manufacturing plant in Palghar, India, earlier this year.…
For $200 million up front and a possible $4.3 billion later, Arcturus Therapeutics has agreed to a vaccine collaboration with CSL Seqirus. Source: Drug Industry Daily
Two gene replacement therapies to combat hemophilia are worth multimillion dollar price tags because they would eliminate the need for ongoing treatment with high-priced anticoagulant drugs, says the Institute for…
An FDA advisory committee voted 9-0 yesterday in favor of the agency’s proposal to create an as-yet undefined rating system to incentivize drug manufacturers to adopt more mature quality management…
A new FDA draft guidance the over-the-counter (OTC) monograph drug user fee program outlines the program’s features and procedures, including the types of fees, due dates, the process for submitting…
The FDA has revised its October 2017 draft guidance on the Expanded Access program, adding information on eligibility criteria, submission process and safeguards intended to protect patients and preserve the…