We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
In publishing Q3D(R2) – Guideline for Elemental Impurities, the FDA has taken another step towards endorsing International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, this time focusing on catalysts and environmental contaminants that may be present in drug substances, excipients or drug products. Read More
After getting fewer than 50 comments on the proposed rule, the FDA has issued its final rule on the annual report pharmaceutical companies must submit on drugs they supplied under the Right to Try Act, a law that allows patients with life-threatening conditions access to certain unapproved investigational drugs and biological products. Read More
FDA’s Real-Time Oncology Review (RTOR) program shaved about two months off the average approval time for cancer therapeutics Genentech has submitted through the program, said Grace Gao, regulatory affairs program manager for Hoffmann-La Roche/Genentech, sharing new data at the annual meeting of the Regulatory Affairs Professionals Society in Phoenix this week. Read More
A New York district judge has once again thrown out a whistleblower complaint alleging that Novartis offered doctors kickbacks to entice them to prescribe its multiple sclerosis blockbuster Gilenya (fingolimod). Read More
The investigational treatment also received Fast Track designation from the FDA in August for the treatment of patients with pulmonary sarcoidosis. Read More
New generic drug approvals in 2018, 2019 and 2020 yielded $53.3 billion in savings, according to a new FDA report that analyzed results from 2,400 approved new generic drug applications. Read More
The day a bench trial was slated to begin in Delaware federal court on Gilead’s five patent disputes with generic drug makers who were poised and ready to make copies of Gilead’s two HIV blockbuster drugs and its hepatitis B drug, the company announced that it had settled the disputes. Read More
All people are not the same. While glaringly obvious, that truth is often ignored in clinical trials. And fixing that problem requires companies to understand and overcome a myriad of barriers, according to a panel discussion held at the annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Phoenix this week. Read More
Planning for a drug or device recall, training for it and executing it with a heaping helping of humility are the key steps to managing a recall without sinking your business, according to Matt Walker, director of business development for the risk management company Sedgwick. Read More