Drugs
The American Society of Health-System Pharmacists (ASHP) has approved a policy that urges Congress to ban all direct-to-consumer (DTC) advertising of prescription drugs and medication-containing devices. The new policy, which was adopted earlier this month by the organization’s House of Delegates, is a reversal of
FDA Policy/General
Federal Register Notice: FDA intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) Account Management function. The agency will need participation from a small group of filers, importers of record, and consignees, who will use the new ITACS Account Management function
FDA Policy/General
Federal Register Notice: FDA is making available its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonization (ICH) E2B(R3) Specification. It is making this document available to assist interested parties in electronically submitting individual case safety reports and attachments to CDER and CBER.
FDA Policy/General
Federal Register Notice: FDA is amending a 6/16 notice of meeting of the Pediatric Oncology Subcommittee to reflect a change in the Procedure portion of the document. The meeting is scheduled to discuss six products in various stages of development for adult cancer indications and the current unmet clinical
FDA Policy/General
Federal Register Withdrawal of notice: FDA withdraws a 6/2 Federal Register notice, which announced that a proposed collection of information, “Guidance for Industry on Nonproprietary Naming of Biological Products,” had been submitted to the Office of Management and Budget. To view this notice, click here.
FDA Policy/General
Federal Register Final rule: FDA is amending certain regulations on donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products, and related labeling. This final rule is in response to the agency’s enhanced understanding in this area and in
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Xofigo is 1,945 days for extending a patent which claims the human drug product. FDA has approved for marketing the human drug product Xofigo (radium 223 dichloride) for treating patients with castration-resistant prostate cancer, symptomatic bone metastases
FDA Policy/General
Final order: FDA is classifying the gynecologic laparoscopic power morcellation containment system into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the gynecologic laparoscopic power morcellation containment system’s classification. To
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Pure Whey, LLC Raleigh, NC (5/24). Inspected New Bern, NC facility 9/15-18/15. CGMP deviations, adulterated, misbranded: The American Pure Whey 100% Pure Whey Matrix
FDA Policy/General
A Heritage Foundation legal memorandum says there can be no doubt that “the existing FDA regulatory system is less than satisfactory and requires substantial and timely reform. Now is the time to begin seriously to explore the contours of such reform.” The paper says that much of the discussion about
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Medical Device Accessories,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice,
FDA Policy/General
Federal Register Notice: FDA is making available a final guidance entitled Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff. It explains the circumstances in which it may be appropriate to extrapolate existing medical device data to support
FDA Policy/General
BIOLOGICS Panel to Discuss Amgen’s Humira Biosimilar Federal Register Notice: FDA will hold a meeting of the Arthritis Advisory Committee 7/12, from 7:30 a.m. to 5 p.m. at : FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503)
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications. It provides recommendations on the submission of chemistry, manufacturing, and controls and pharmacokinetic information, as well as procedures to follow, to support the approval of modified
FDA Policy/General
Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommendations. They provide product-specific guidance on the design of BE studies to support ANDAs. The products include amcinonide, cobimetinib fumarate, selexipag, and tacrolimus. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Quality Attribute Considerations for Chewable Tablets. It describes the agency’s thinking on the critical quality attributes that should be assessed when developing a chewable tablet dosage form and recommends that the selected acceptance criteria be appropriate
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Evaluation of FDA’s General Market Youth Tobacco Prevention Campaigns,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is issuing two Emergency Use Authorizations for two in vitro diagnostic devices for detecting Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these authorizations under the FD&C Act, as requested by Focus Diagnostics, Inc., and Altona Diagnostics GmbH.
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Boston Scientific Scimed, Inc’s Zilver PTX Drug Eluting Peripheral Stent is 3,075 days for extending patents that claim the medical device.The stent is indicated for improving luminal diameter for the treatment of de novo or restenotic
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Cook Medical’s Zilver PTX Drug Eluting Peripheral Stent is 3,075 days for extending a patent that claims the medical device. The stent is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Eli Lilly’s Orbactive (oritavancin diphosphate) is 6,539 days for extending a patent that claims the human drug product. Orbactiv is indicated for treating adult patients with acute bacterial skin and skin structure infections caused or suspected to