FDA Policy/General
Federal Register notice: FDA has announced its decision to exempt a list of Class 2 devices from premarket notification requirements. Comments are being accepted until 12/24 on the exempt devices. They are: * Accessory, Assisted Reproduction (product code MQG): Exemption is limited to assisted reproduction laminar flow workstations * Media, Reproductive
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.” The guidance revises a 2011 document to describe the multiple factors that the agency considers before requiring a postmarketing study
FDA Policy/General
Federal Register notice: FDA is making available a publication containing modifications the agency is making to the list of standards it recognizes for use in premarket reviews (FDA Recognized Consensus Standards). The listing, “Modifications to the List of Recognized Standards, Recognition List Number: 052” is intended to assist manufacturers who
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Breast Implants — Certain Labeling Recommendations to Improve Patient Communication.” The document contains recommendations about the content and format for certain labeling information for saline- and silicone gel-filled breast implants. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Data to Support Social and Behavioral Research as Used by the Food and Drug Administration” (OMB Control Number 0910-0847). FDA says it is important to understand patients, consumers, and healthcare professionals’ perceptions and behaviors to improve
FDA Policy/General
The Washington Post says it has learned that President Donald Trump is about to name MD Anderson chief medical officer Stephen Hahn to be FDA commissioner, succeeding acting commissioner Ned Sharpless. The Post says Hahn, 59, is a radiation oncologist and researcher who has been described as an “energetic consensus-
FDA Policy/General
FDA and FTC have posted a joint Warning Letter to Rooted Apothecary (Naples, Florida) for illegally selling unapproved products containing cannabidiol online that made unsubstantiated claims for treating teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder, Parkinson’s and Alzheimer’s disease, among other conditions or
FDA Policy/General
FDA said it has granted its first authorizations for marketing eight smokeless tobacco products approved through the modified risk tobacco product pathway. The authorizations are for eight Swedish Match USA, Inc., snus smokeless tobacco products sold under the “General” brand name. An agency statement says the products were previously authorized
FDA Policy/General
Draft Guide on Drug Master Files Federal Register notice: FDA makes available a draft guidance entitled “Drug Master Files.” 10/18/2019 10 Info Collections Approved by OMB Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB. 10/18/2019 FDA/
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Drug Master Files.” The document provides FDA’s current thinking on submissions that may be used to provide confidential, detailed information about facilities, processes, or articles used in drug product manufacturing, processing, packaging, and storing. of human drug products.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB. They are: 1. Export of Medical Devices; Foreign Letters of Approval 2. Registration of Food Facilities 3. Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of
FDA Policy/General
Federal Register notice: FDA announces an 11/4 regional public meeting entitled “Health Canada and U.S. Food and Drug Administration Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting is scheduled to solicit public input on the current
Drugs
The Federal Trade Commission (FTC) says Nature City, Boca Raton, FL, which markets two aloe vera-based supplements, has agreed to pay $537,500 to settle charges that it deceived consumers with false and unsupported claims that its TrueAloe and AloeCran were effective treatments for a range of conditions affecting
FDA Policy/General
Federal Register notice: FDA is requesting nominations for a nonvoting representative to serve on the Tobacco Products Scientific Advisory Committee. In addition, it is requesting that any industry organizations interested in participating in the selection of a nonvoting representative notify the agency in writing. To view the notice, click here.
Drugs
Washington Legal Foundation (WLF) says an FDA proposed rule to require photorealistic color graphics to accompany textual warnings on cigarette packs violates the First Amendment. In comments to the agency, WLF challenges the FDA claim that because a significant information gap exists, the proposed rule is necessary to inform the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Potential Tobacco Product Violations Reporting Form” (OMB Control Number 0910-0716). The form is related to the agency’s authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Glenmark Pharmaceuticals, Mumbai, India (10/3): FDA inspected the firm in April and cited significant GMP violations for finished pharmaceuticals. For example, Glenmark failed to thoroughly investigate multiple complaints
FDA Policy/General
A 10/14 New York Times article examines FDA’s and the federal government’s alleged foot-dragging over the last decade that allowed e-cigarette use and marketing to explode to the detriment of teenagers. “In dozens of interviews, federal officials and public health experts described a lost decade
FDA Policy/General
CDRH Listing on Upcoming Guidance Documents Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in fiscal year 2020. 10/11/2019 Info Collection on 510(k) 3rd-party Reviews Federal Register notice: FDA submits
FDA Policy/General
DEVICES FDA has approved an Aspire Bariatrics PMA for the AspireAssist, a new obesity treatment device that uses a surgically-placed tube to drain stomach contents after every meal. “The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for
FDA Policy/General
Federal Register notice: FDA has announced its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in fiscal year 2020. In addition, FDA has established a docket where comments are being accepted on prioritizing topics for guidance development. One listing outlines
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “510(k) Third-Party Review Program” (OMB Control Number 0910-0375). The program permits FDA to accredit persons in the private sector to review certain 510(k)s. A third party wishing to participate needs to submit