Drugs

FDA Outlines Disposition of Covid-19 Guidances

FDA has published a Federal Register notice outlining the status of the many guidance documents that were issued to address the Covid-19 public health emergency (PHE), which will officially end 5/11. Because many of the guidance documents issued during the PHE to address Covid-19 were tied to the duration of the PHE, the Federal Register notice clarifies when certain guidances will no longer be in effect and which guidances FDA is revising to continue in effect after the PHE declaration ends. FDA notes that the termination of the PHE declaration will not impact its ability to authorize Covid-19 treatments for emergency use while the applicable declaration enabling the issuance of EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act is in place.

In the notice, FDA has identified 22 guidances that should no longer be in effect upon expiration of the Covid-19 PHE declaration. Most of these guidances state that they are intended to remain in effect only for the duration of the declared Covid-19 PHE.

Another 22 identified guidances will expire after a 180-day wind-down period. additional wind-down period is appropriate to allow for an orderly transition. FDA has determined that for these guidances, stakeholders such as industry, healthcare providers, patients, consumers, and FDA would benefit from additional time to transition from the policies adopted during the Covid-19 PHE. After 11.7, they will no longer be in effect.

And, another 24 guidances will be retained with appropriate changes after expiration PHE expires. “Therefore, FDA is revising the 24 guidances … to continue in effect for 180 days after the Covid-19 PHE declaration expires,” the notice says. “During that time, FDA plans to further revise each of these guidances with any appropriate changes based on comments received and the agency’s experience with implementation…Once a revised final guidance is issued, which could occur sooner than 180 days after the PHE declaration expires…”

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