FDA Policy/General

Latest Federal Register Notices

OMB Approves 6 FDA Information Collections
5/7/2021 Federal Register notice: FDA has announced the following information collections have been approved by OMB:

Applications for FDA Approval to Market a New Drug (0910-0001)
Medical Devices; Humanitarian Use Devices (0910-0332)
Medical Devices; Device Tracking (0910-0442)
Dispute Resolution Procedures for Science Based Decision on Products Regulated by CVM (0910-0566)
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics (0910-0850)
Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion (0910-0895)

To view the notice, click here.

Info Collection on Medical Product Communications
5/7/2021 Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers” (OMB Control Number 0910-0856). The collection supports FDA regulations that govern drug and device labeling and prescription drug and restricted device advertising. To view the notice, click here.

Condom Labeling Information Collection
5/7/2021 Federal Register notice: FDA has submitted to OMB and information collection extension entitled “Class 2 Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.” To view the notice, click here.

Info Collection on Device Classification Inquiries
5/6/2021 Federal Register notice: FDA has submitted to OMB an information collection extension entitled “513(g) Request for Information” (OMB Control Number 0910-0705). The collection supports FDA regulations and guidance related to obtaining the agency’s views about the classification and regulatory requirements that may be applicable to a particular device. To view the notice, click here.

Pharmacy Compounding Advisory Panel Meets 6/9
5/6/2021 Federal Register notice: FDA has announced a 6/9 Pharmacy Compounding Advisory Committee meeting. Panel members are scheduled to discuss four bulk drug substances nominated for inclusion on the 503A Bulks List — choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin. 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