Drugs

MAPP on Alternative Compendia Standards

The CDER Office of Pharmaceutical Quality has issued a Manual of Policies and Procedures (MAPP), Acceptability of Standards from Alternative Compendia (BP/EP/JP), to clarify for reviewers the appropriate use of quality standards for excipients, drug substances, and drug products found in the British, European, and Japanese pharmacopeias. The standards are used during chemistry, manufacturing, and controls review of INDs and NDAs, the document says.

The MAPP is not intended to establish the three foreign compendia as official compendia in place of or in addition to the United States Pharmacopeia/National Formulary. And it is not intended to preclude any current efforts to establish a process for evaluation and regulatory acceptance of harmonized analytical procedures and/or acceptance criteria.

According to the MAPP, it “is reasonable to accept an applicant’s proposal to use a quality standard” from one of the three named foreign compendia as part of the application for an excipient, drug substance, or drug product in the drug application if the foreign compendium’s standard is equivalent to or better than the corresponding standard in the U.S. compendium. It says that equivalent standards have the same acceptance criteria and make use of analytical procedures based on similar principles. A standard can be considered better that a corresponding standard for several reasons, it says, including narrower ranges for acceptance criteria or superior performance of the analytical procedure.

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

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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