Drugs
In recognition of recent court decisions that have been protective of off-label promotion, CDER director Janet Woodcock has acknowledged that the pendulum has swung away from aggressive FDA drug advertising and promotion enforcement. Addressing an Alliance for a Stronger FDA gathering in Washington, DC 9/21, Woodcock was asked
FDA Policy/General
Federal Register notice: FDA has announced an 11/15 Patient Engagement Advisory Committee meeting to discuss and make recommendations on the topic “Connected and Empowered Patients: E-Platforms Potentially Expanding the Definition of Scientific Evidence.” The recommendations will address how FDA can leverage patient-driven platforms, such as social media
FDA Policy/General
Federal Register notice: FDA has announced an 11/1 joint Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to review an Alkermes NDA for buprenorphine and samidorphan sublingual tablets, indicated as an adjunctive treatment of major depressive disorder. To view the
FDA Policy/General
FDA’s fiscal year 2019 Congressional appropriations, which are part of a four-bill minibus, are “imperiled” after being superseded by other spending bills and lawmakers push for an early recess in order to campaign in the mid-term elections, according to an analysis by the Alliance for a Stronger
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.” The document discusses civil money penalties that may be assessed against responsible parties
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Product Identifier Requirements Under the Drug Supply Chain Security Act— Compliance Policy.” The is document describes FDA’s intention to enforce a Drug Supply Chain Security Act provision requiring manufacturers to begin affixing or imprinting product identifiers on their
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” The document addresses several revisions of the United States Pharmacopeia drug substance monograph for heparin sodium, and drug product monographs for heparin lock flush solution and
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” This guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier will (XXX SUBSTITUTE XXX)be grandfathered
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.” The document intends to clarify questions relating to product identifiers that are required by the Drug Supply Chain Security Act for packages and homogenous cases of certain
FDA Policy/General
Federal Register notice: FDA is correcting an incorrect docket number appearing in a 9/11 Federal Register notice entitled “Post-approval Changes to Drug Substances; Draft Guidance for Industry; Availability.” The notice is now corrected to read “Docket No. FDA–2018–D–3152.” To view the notice, click here.
FDA Policy/General
A Justice Department memo to civil litigators throughout the country lays out arguments to be made when seeking to limit courts from applying “overbroad injunctive relief” in cases involving “nationwide injunctions.” Attorney Anne Walsh (Hyman, Phelps & McNamara) writes in an online post that a “nationwide injunction” is one in
FDA Policy/General
Federal Register notice: FDA has established a public docket to collect comments related to the post-marketing, pediatric-focused safety reviews of products posted between 4/2 and 9/14 on FDA’s Web site but not presented at a planned 9/20 Pediatric Advisory Committee meeting. The reviews are
FDA Policy/General
Federal Register notice: FDA has announced a 10/24-25 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the agency’s “Guidance for Industry: Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” The agency is promoting the panel meeting as a review of
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ITG-Medev San Francisco, CA (9/7): FDA inspected the firm in June and cited GMP deficiencies with its device, the Omiderm wound dressing. For example, the firm failed
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Oncologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 9/1/2020. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is correcting a notice entitled “Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments” that appeared in the 9/11 Federal Register. The notice was published with an incorrect docket number. The correct docket number is FDA-
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection entitled “Clinical Use of Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities” (OMB Control Number 0910-NEW). The information collection would support agency-sponsored research. To evaluate nominated substances, FDA has proposed a research study
Drugs
House Republicans last week derailed a Trump-supported amendment to a health care spending bill that would have required drug companies to include prices in their direct-to- consumer advertising. Last month, the Senate passed the bipartisan amendment introduced by Sens. Chuck Grassley (R-IA) and Dick Durbin (D-IL)
FDA Policy/General
Federal Register notice: FDA has announced an 11/28 public workshop entitled “Pathogen Reduction Technologies for Blood Safety.” The workshop is intended to foster the development and implementation of pathogen reduction technologies for blood components intended for transfusion. It will include presentations and panel discussions by experts from academic institutions,
FDA Policy/General
Guide on Consensus Standards Recognition/Withdrawal Federal Register notice: FDA makes available a draft guidance entitled “Recognition and Withdrawal of Voluntary Consensus Standards.” 09/14/2018 Draft Guide on 510(k) Third-Party Review Program Federal Register notice: FDA makes available a draft guidance entitled “510(k) Third-Party Review
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Recognition and Withdrawal of Voluntary Consensus Standards.” The document identifies the principles FDA uses for recognizing a standard, and it explains the extent of recognition and other supplementary information. It provides information on how parties may request recognition as
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “510(k) Third-Party Review Program.” The document reflects amendments made to the third-party review program by the FDA Reauthorization Act of 2017, which directed the agency to issue draft guidance on the factors that will be used