Drugs

Comments on Draft Indications and Usage Labeling Guidance

The Biotechnology Innovation Organization (BIO) applauds an FDA draft guidance with recommendations on general principles to consider when drafting an indication and how to write, organize, and format the information in the Indications and Use section of labeling. The BIO letter particularly commends the agency for recognizing that an indication for a broader population than the population studied in controlled trials may be appropriate after careful consideration of the generalizability of the evidence, consistencies in the disease process across different groups, and the drug’s overall benefits and risks. It suggests ways in which the section on identification of outcomes, endpoints, and benefits the drug conveys could be strengthened, and says the agency should ensure that labeling preserves the intent of accelerated approval to hasten availability of treatments for patients with serious or life-threatening diseases and limited or no treatment options.

In its letter, Pharmaceutical Research and Manufacturers of America says the draft guidance gives sponsors general information to draft informative labeling for drug and biological products, but could use clarification on how FDA plans to apply the draft’s principles in specific circumstances. It offers comments on the guidance scope, the approval process for and requirement to revise labeling, and the process for limitations of use.

Sarepta Therapeutics says it “agrees with many of the recommendations and general principles contained in the draft guidance and believes it will lead to greater alignment and transparency across labeling practices overall.” It gives suggestions for revisions in terms of age groups in indications and accelerated approval.

Pfizer submitted specific line-by-line comments.

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