FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.” The document is intended to inform manufacturers, members of the medical and scientific community, and other interested persons that at this time FDA
FDA Policy/General
FDA and IBM Watson Health have agreed on a two-year research initiative to define a secure, efficient, and scalable exchange of healthcare data using blockchain technology. An IBM statement says that the two parties will explore the exchange of owner-mediated data from several sources such as electronic medical
FDA Policy/General
Federal Register Notice: FDA has announced the availability of a draft guidance entitled “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.” The document is intended to promote the safe use of nonprescription aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing
FDA Policy/General
Federal Register Notice: FDA is seeking comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The drug substances are recommended to be placed in Schedule I of the Single Convention on Narcotic Drugs (1961). To view the
FDA Policy/General
FDA commissioner Robert Califf plans to officially resign on Inauguration Day (1/20), according to the agency. While FDA is being tight lipped on his replacement, it is assumed that next-in-line deputy commissioner Stephen Ostroff will take the reigns as acting commissioner — a position he handled after former
FDA Policy/General
The Federal Trade Commission and the New York State attorney general have filed claims in a New York federal court charging the marketers of the dietary supplement Prevagen with making false and unsubstantiated claims that the product improves memory, provides cognitive benefits, and is “clinically shown” to work. FTC says
FDA Policy/General
Federal Register Notice: FDA has asked for comments on an information collected extension related to its guidance on “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.” The document describes FDA’s interpretation on how determines if: (1)
FDA Policy/General
Rep. Tom Price (R-GA), the doctor who has been nominated as HHS secretary, has worked hard during his time in Congress to keep federal dollars flowing to his most generous campaign donors, according to a Kaiser Health News report. The report says a review of the congressman’s records
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance entitled “Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.” The document addresses questions about FDA’s expectations for annual reporting by prescription drug wholesale distributors and third-party logistics providers. To view the
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says that FDA’s use of character-space-limited social media platforms such as Twitter “should set the industry standard for appropriate utilization of these media.” Responding to an agency research proposal involving character-space-limited online prescription drug communications, PhRMA says it
FDA Policy/General
Federal Register Notice: FDA has extended the comment period for a revised draft guidance entitled “Submission of Quality Metrics Data” that was published in the 11/25/2016 Federal Register. The document describes FDA’s plans for an initial, voluntary phase of its quality metrics program that will allow the
FDA Policy/General
Federal Register Notice: FDA has announced a 3/23 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting. The panel will discuss and make recommendations on clinical information related to a de novo request for the Claret Medical’s Sentinel Cerebral Protection System, an embolic protection device intended
FDA Policy/General
Federal Register Notice: FDA has announced an Emergency Use Authorization issuance to ELITechGroup Molecular Diagnostics for an in vitro diagnostic device for detecting the Zika virus. To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA is seeking information and comments about how it plans to administer generic drug program fees beginning in fiscal year 2018 (10/1). Under the user fee program, a fee will be assessed under a three tier system based on application holders. To view the notice, click
FDA Policy/General
While FDA’s consolidated campus in White Oak, MD has offered more collaboration opportunities and efficiencies such as shared laboratories, the campus and its use has grown rapidly and remains a high-risk security concern, according to a new Government Accountability Office report. “(D)ue to concerns about managing traffic
FDA Policy/General
DEVICES Surgical Tools for Urogynecologic Mesh Reclassified Federal Register Final Order: FDA has reclassified surgical instrumentation for use with urogynecologic surgical mesh from Class 1 (general controls) exempt from premarket notification to Class 2 (special controls) subject to premarket notification, and identifying them as ‘‘specialized surgical instrumentation for use with
FDA Policy/General
Federal Register Final Order: FDA has reclassified surgical instrumentation for use with urogynecologic surgical mesh from Class 1 (general controls) exempt from premarket notification to Class 2 (special controls) subject to premarket notification, and identifying them as ‘‘specialized surgical instrumentation for use with urogynecologic surgical mesh.’’ FDA is designating special
FDA Policy/General
FDA has accepted for priority review two Melinta Therapeutics NDAs for intravenous and oral Baxdela (delafloxacin) for treating patients with acute bacterial skin and skin structure infections (ABSSSI). Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA), according
Drugs
Lilly says that the research objectives and study approach for an FDA study of character-space-limited online prescription drug communication generally seem reasonable. The research is to examine two hypotheses, it says in a comment letter. The first is that participants who see substantive risk information in character-space-
FDA Policy/General
Federal Register Notice: FDA has announced a 4/6 public workshop entitled “Emerging Tick-Borne Diseases and Blood Safety” that will discuss tick-borne pathogens that continue to emerge as threats to blood safety. It will also review the effectiveness of current and potential mitigation strategies, and theg eneral approach
FDA Policy/General
Federal Register notice: FDA has renewed its Technical Electronic Product Radiation Safety Standards Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 12/24/2018. To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA is seeking comments on a new information collection, “Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion.” The proposed research is intended to determine how well consumers and healthcare professionals can identify and respond to deceptive prescription drug promotion. “The ability to