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The FDA has until March 5 to provide an answer for Vanda Pharmaceuticals’ five-year quest to understand why the FDA denied the company’s supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) — filed in October 2018 — as a treatment for jet lag disorder, a federal judge has ruled. Read More
The FDA has expanded its use of in-person face-to-face (FTF) meetings for additional application types, and have expanded its definition of FTF meetings to include hybrid meetings which combine in-person and virtual attendance. Read More
In this edition of Quick Notes, we hop across the pond to check out the EMA’s new regulatory fees structure, its updated submissions communication portal, and the sixth update of its guideline on the clinical evaluation of anticancer medicinal products. Read More
Strong nonclinical testing should underpin development programs for both gene editing (GE) products and chimeric antigen receptor (CAR-T) cellular products, according to two new final guidances issued by the FDA. Read More
Manufacturers with tentatively approved ANDAs can look to a recently issued FDA final guidance for information on how to prepare and submit amendments as well as make requests to get faster final approval. Read More
Generic drugmakers Apotex, Heritage and Breckenridge have agreed to settle for a combined $45 million over allegations that they colluded to fix prices. Read More
The FDA is offering drugmakers the opportunity to become involved in an agency effort to find ways to evaluate quality management maturity (QMM) by using a prototype assessment protocol. Read More
While secondary T-cell cancers following CAR-T cell therapy are relatively rare adverse events, the FDA wants its new boxed warning labeling changes for the drugs to encourage more data on outcomes, agency officials said in an editorial. Read More
The Department of Justice (DOJ) and HHS issued a joint letter to state Medicaid administrators urging them to act in accordance with the Americans with Disabilities Act (ADA) and allow access to life-saving hepatitis C medications to people who have both hepatitis C and substance use disorder. Read More