Drugs

Hahn Outlines Covid, Other Agency Successes

FDA commissioner Stephen Hahn says the agency has prioritized the assessment of generic drug submissions involving potential treatments and supportive therapies for patients with Covid-19. Speaking 11/9 to the GRx+Biosims virtual conference, he also said FDA has worked closely with generic drug applicants whose development work has been affected by the pandemic.

“We’ve supported manufacturers of approved generic drug products who need to change a manufacturing process or facility to address resulting disruptions, such as quarantines, infection outbreaks among employees, site closures, [and] travel limitations, as well as supported applicants who experienced interruptions to the supply chain for the proposed generic product or the reference-listed drug,” he said.

Demonstrating how FDA has continued to work on non-Covid activities while also addressing the pandemic, Hahn said that in FY 2020 the agency approved or tentatively approved more than 900 generic drugs, including 74 first generics. It also approved more than 30 original ANDAs, including many drugs with increased demand related to the public health emergency, as well as products used to treat secondary conditions associated with Covid-19.

In FY 2020, according to Hahn, the agency met most of its user fee goals for drugs by reviewing and acting on at least 90% of branded, generic, and biosimilar drug applications.

FDA has resumed prioritized domestic surveillance inspections, Hahn said, and is using all available tools and sources of information to support regulatory decisions on applications that include sites affected by FDA’s ability to inspect due to Covid-19.

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