FDA Policy/General

Federal Register Notices 6/28 to 7/2

7/2/2021

Topical and Transdermal Adhesion Assessments Guide

Federal Register notice: FDA has made available a draft guidance entitled Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications. To view the notice, click here.

Guide on CNS Cancer Drugs

Federal Register notice: FDA has made available a final guidance entitled Evaluating Cancer Drugs in Patients with Central Nervous System Metastases. To view the notice, click here.

Guide on Alternate Electronic Submission Formats

Federal Register notice: FDA has made available a final guidance entitled Providing Regulatory Submissions in Alternate Electronic Format. To view the notice, click here.

Priority Voucher Awarded to Prometic Bio

Federal Register notice: FDA has issued a priority review voucher to Prometic Bioproduction for gaining approval of a rare pediatric disease product application — Ryplazim (plasminogen, human-tvmh), indicated for treating patients with plasminogen deficiency Type 1 (hypoplasminogenemia). To view the notice, click here.

Panel Meeting to Review Keystone Heart 510(k)

Federal Register notice: FDA has announced an 8/3 Medical Devices Advisory Committee meeting of its Circulatory System Devices Panel. The meeting will review a Keystone Heart 510(k) for the TriGuard 3 Cerebral Embolic Protection Device. To view the notice, click here.

6/30/2021

Comments Sought on MedWatch Info Collection

Federal Register notice: FDA is seeking comments on an information collection extension entitled “MedWatch: The FDA Medical Products Reporting Program” (OMB Control Number 0910-0291). To view the notice, click here.

Info Collection on Adverse Event Reporting

Federal Register notice: FDA is seeking comments on an information collection extension entitled “Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biologics Products” (OMB Control Number 0910-0230). To view the notice, click here.

Corrected Notice on Patient Transport Petition

Federal Register notice: FDA is correcting a 6/5 notice announcing receipt of a petition requesting 510(k) exemption for powered patient transports. The document was published with an incorrect docket number, which is now corrected to read: “Docket No. FDA–2021–P–0424.” To view the notice, click here.

6/28/2021

Guide on Drug Safety Reporting Requirements

Federal Register notice: FDA is making available a draft guidance entitled Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies. To view the notice, click here.

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