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Closing on May 31, the European Medicines Agency (EMA) has opened a second consultation for its guideline on requirements for investigational advanced therapy medicinal products (ATMP) in clinical trials. Read More
The FDA on Monday announced creation of the new Quantitative Medicine (QM) Center of Excellence to facilitate and coordinate the continuous evolution and consistent application of QM across CDER. Read More
The FTC has filed an amicus brief in a suit between Teva Pharmaceuticals and Amneal Pharmaceuticals, supporting Amneal and saying Teva has improperly listed the patents in dispute in the FDA’s Orange Book, and urged the court to order Teva’s listings removed. Read More
This edition of Quick Notes reviews four CHMP positive opinions, including a once-weekly insulin treatment for patients with type 2 diabetes, an oral monotherapy for patients with a rare blood disease, a new antibiotic to treat multi-drug resistant bacteria, and a generic multiple sclerosis drug treatment. Read More
In a nod to the increasing potential of demonstrating drug/biologic safety and/or effectiveness through noninterventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with real-world data (RWD) in mind. Read More
Medicare coverage of anti-obesity medications (AOM) — now CMS approved for cardiac patients — could drive up the federal deficit over the next decade, according to a new report issued by the Congressional Budget Office (CBO). Read More
The EU’s Environment, Public Health and Food Safety Committee (ENVI) has supported a legislative proposal that would grant up to 7.5 years of regulatory data privacy to pharmaceutical companies developing new drugs, effectively trimming six months of protection from the current eight years for some products. Read More
An FDA proposed rule will establish criteria the agency will use to create two lists — drug products and categories of drug products — that present demonstrable difficulties for compounding (DDC Lists) and identify three categories of drug products on both DDC Lists. Read More
Recommendations for drug sponsors to assess the impact of impaired renal function on pharmacokinetics (PK) and/or pharmacodynamics (PD) of an investigational drug, how to determine the recommended dosage, and how to provide appropriate labeling are the subjects of a recently released FDA final guidance. Read More