Drugs

Generic Drug Review Prioritization MAPP

CDER has issued a Manual of Policies and Procedures (MAPP) describing how the review of original ANDAs, ANDA amendments, and ANDA supplements will be prioritized within the Office of Generic Drugs and the Office of Pharmaceutical Quality. The MAPP establishes public health priorities (prioritization factors) that may qualify an original ANDA, amendment, or supplement for a priority review. The factors are:

submissions containing certain patent certifications and exclusivity statements;
submissions related to drug shortages;
submissions subject to special review programs such as the President’s Emergency Plan for AIDS relief;
submissions related to public health emergencies;
submissions related to certain government purchasing programs;
submissions subject to mandatory mandates or other legal requirements;
supplements for which a priority review is requested for public health reasons when a delay would cause extraordinary hardship on the applicant;
submissions for “sole source” drug products.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome