FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions. It is intended to provide clarity for FDA staff and industry on the benefit and risk factors the agency may consider in prioritizing resources
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Use of International Standard ISO 10993-1, `Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.’ FDA aims to assist industry in preparing PMAs, Humanitarian Device Exceptions, Investigational Device Applications (IDEs), Premarket Notifications (510(
FDA Policy/General
Federal Register Notice: FDA’s Office of Pediatric Therapeutics, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development will hold a two-day public workshop 9/12-13 entitled “Pediatric Clinical Investigator Training.” Its purpose is to provide investigators with training and expertise in designing and
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee6/28 from 8 a.m. to 3:15 p.m. and 6/29, from 8 a.m. to 4:15 p.m. at FDA’s White Oak Campus, 10903 New Hampshire
FDA Policy/General
BIOLOGICS Comments Sought on Human Tissue Info Federal Register Notice: FDA is seeking comments on the proposed information collection requirements relating to FDA regulations for human tissue intended for transplantation. Comments should be submitted by 8/5. To view this notice, click here. Comments Extended on Biosimilar Guidance Federal Register
FDA Policy/General
Federal Register Notice: FDA’s Center for Tobacco Products is inviting participation in its Tobacco Product Manufacturing Facility Visits. The program is intended to give FDA staff an opportunity to visit facilities involved in the manufacturing of newly deemed tobacco products and their components and parts, including any related laboratory
FDA Policy/General
The Government Accountability Office (GAO) says that FDA lacks measurable goals with which to assess its progress in advancing regulatory science. “The agency issued strategic planning documents in 2011 and 2013 to guide its regulatory science efforts and identify priority areas for conducting work,” the GAO says in a new
FDA Policy/General
Federal Register Notice: FDA is releasing “Modifications to the List of Recognized Standards, Recognition List Number: 042,” a publication containing modifications it is making to the list of standards that it recognizes for use in premarket device review. It will assist manufacturers who elect to declare conformity with consensus standards
FDA Policy/General
Federal Register Final rule: FDA is revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as “stand-alone symbols”) if certain requirements
FDA Policy/General
The FDA strategic integrated management plan (SIMP) for its three Centers overseeing medical products (CBER, CDER, CDRH) does not include leading practices for strategic planning or document a comprehensive strategy for the Centers, according to a new Government Accountability Office report. In 2012, Congress required the agency to develop a
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Austin Biotechnology Inc. Taipei, Taiwan (6/2). Inspected 5/28-29/15. GMP deviations, adulterated: The firm failed to establish a quality control unit with the responsibility and authority
FDA Policy/General
FDA assistant commissioner for minority health Jonca Bull says the agency is launching a campaign to encourage minorities to participate in clinical trials for all medical conditions. Writing in an FDA Voice blog post, Bull says the campaign will launch 6/19, World Sickle Cell Day, to “encourage diverse communities
FDA Policy/General
FDA says it is working with the Clinical Trials Transformation Initiative (CTTI) to create a new work group with patient advocacy organizations to talk about patient engagement at the agency. An FDA notice says that the agency will leverage CTTI’s strengths in multi-stakeholder engagement to coordinate the new
Drugs
The Washington Legal Foundation says that many state attorneys general view drug companies as “their own private cash cow.” A Legal Opinion Letter by two Arnold & Porter attorneys outlines a recent South Carolina Supreme Court decision against Janssen over its Risperdal marketing. In 2003, FDA required all drugs in
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment. It provides recommendations to industry for designing a nonclinical development program to support approval of drugs to treat osteoporosis. It also discusses the nonclinical development of biopharmaceuticals (e.g.
FDA Policy/General
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 the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss
FDA Policy/General
Paradigm Spine has agreed to pay the U.S. government $585,000 to resolve allegations under the False Claims Act that it caused health care providers to submit false claims to Medicare and other federal health care programs by marketing the company’s coflex-F device for unapproved uses, according
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Dissemination of Patient-Specific Information from Devices by Device Manufacturers. The agency intends to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients. The
FDA Policy/General
Federal Register Notice: FDA is making a draft guidance available for industry entitled Oncology Drugs for Companion Animals. It provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a NADA for certain oncology drugs, and provides
FDA Policy/General
Federal Register Notice: FDA will hold a meeting 7/13 of the Arthritis Advisory Committee, 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), Silver Spring, MD. The committee will discuss a
FDA Policy/General
Federal Register Notice: FDA's Dermatologic and Ophthalmic Drugs Advisory Committee will meet 7/19, from 8 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Celgene Corp.'s Pomalyst (pomalidomide) is 3,716 days for extending a patent which claims the human drug product. Pomalyst is indicated for treating patients with multiple myeloma who have received at least two prior therapies including lenalidomide