FDA Policy/General

Latest Federal Register Notices

Stakeholder Participation in Device User Fee Talks
Federal Register notice: FDA is requesting notification from public stakeholders of their intent to participate in periodic consultation meetings on reauthorizing the Medical Device User Fee Amendments (MDUFA). Agency regulations require it to hold discussions (at least every month) with patient and consumer advocacy groups during FDA’s negotiations with regulated industry. The meetings will take place virtually and will be held by Webcast only. To view the notice, click here. 2/19/2021

Covid-19 Guidance Documents Availability
Federal Register notice: FDA is announcing the availability of recent guidance documents related to the Covid–19 pandemic. The guidances have been implemented without prior comment, but they remain open for comment under the agency’s good guidance practices. They are available on FDA’s Web pages entitled COVID–19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders. 2/19/2021

Expedited Programs for Drugs/Biologics Info Collection
Federal Register notice: FDA has submitted to OMB an information collection extension for “Expedited Programs for Serious Conditions — Drugs and Biologics” (OMB Control Number 0910-0765). The collection supports agency regulations and associated guidance that establish procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely debilitating illnesses, especially where no satisfactory alternative therapy exists. To view the notice, click here. 2/18/2021

Comments Sought on WHO Drug Scheduling Recommendations
Federal Register notice: FDA is seeking comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions on certain drug substances. The comments received in response to the notice will be considered in preparing the U.S.’s position on these proposals for an April meeting of the United Nations Commission on Narcotic Drugs in Vienna, Austria. The following recommendations were provided by the WHO’s Expert Committee on Drug Dependence:

Substance recommended to be added to Schedule I of the 1961 Convention — Isotonitazene
Substances recommended to be added to Schedule II of the 1971 Convention — Cumyl-Pegaclone; MDMB-4en-Pinaca; 3-Methoxyphencyclidine, and; Diphenidine
Substances recommended to be added to Schedule IV of the 1971 Convention: —Clonazolam; Diclazepam, and; Flubromazolam

To view the notice, click here. 2/18/2021

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