FDA Policy/General
The Senate Health, Education, Labor and Pensions Committee 1/12 will vote on Robert Califf’s nomination to become the next FDA commissioner. While his earlier nomination hearing was relatively supportive, Califf was grilled by committee member and presidential candidate Bernie Sanders (I-VT), who is concerned about his previous
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to establish device restrictions for sunlamp products, which would restrict their use to individuals age 18 and older, require prospective users to sign a risk acknowledgement certification before use, and require the provision of user manuals. Comments should be submitted by 3/21.
FDA Policy/General
Federal Register Notice: FDA is making available a draft document entitled Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Draft Guidance for Industry. It provides certain establishments that manufacture non-
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the information collection contained in its regulations on current good manufacturing practice for positron emission tomography drugs. Comments should be submitted by 2/29. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff. Its purpose is to make recommendations for 510(k) submissions and complying with special controls being proposed to support reclassification of ECT
FDA Policy/General
Federal Register Notice: FDA is announcing the Web site location where it will post two lists of guidance documents that CDRH intends to publish in Fiscal Year 2016. Also, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Public Notification of Emerging Postmarket Medical Device Signals. It describes the agency’s policy for notifying the public about medical device “emerging signals.” Historically, FDA has communicated important medical device postmarket information after having completed an analysis of available
FDA Policy/General
Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental NADA filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for ThromboGenics’ Jetrea (ocriplasmin) is 2,171 days for extending a patent which claims the human biological product. Jetrea is indicated for treating symptomatic vitreomacular adhesion. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information entitled “Hearing, Aging, and Direct-to-Consumer Television Advertisements” 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 correcting a notice entitled “Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products” that appeared in the 12/15/15 Federal Register. The document was published with an incorrect docket number. To view this notice, click
FDA Policy/General
Federal Register Notice: FDA is announcing the availability of a document entitled Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry. It provides blood establishments that collect blood or blood components, including source plasma, with revised donor deferral recommendations for
FDA Policy/General
Federal Register Notice: FDA is establishing a public docket to receive input on clinical trial designs in emerging infectious diseases. Interested parties are invited to submit comments, supported by research and data, on clinical trial designs. Comments should be submitted by 1/28. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Draft Guidance on Paliperidone Palmitate. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for paliperidone palmitate extended-release injectable suspension. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Unique Device Identification: Convenience Kits; Draft Guidance for Industry and Food and Drug Administration Staff. It is intended to outline the agency’s current thinking that for purposes of Unique Device Identification (UDI) labeling and data submission requirements, the
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. It provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls information containing emerging manufacturing technology. The
FDA Policy/General
Federal Register Notice: FDA’s Allergenic Products Advisory Committee will meet 1/21, from 8:30 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. The committee will meet
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to amend the performance standard for sunlamp products and ultraviolet (UV) lamps intended for use in these products. Comments should be submitted by 3/21. To view this proposed rule, click here.
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. These products must meet
FDA Policy/General
BIOLOGICS Guidance on Reducing HIV Risk in Blood Products Federal Register Notice: FDA is announcing the availability of a document entitled Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry. It provides blood establishments that collect blood or blood components,
FDA Policy/General
FDA acting commissioner Stephen Ostroff says FDA’s focus on regulatory science is helping drive innovation and speed the discovery, development, and delivery of medical products to prevent and cure disease and improve health. Writing a mid-December year-end review FDA Voice blog post, Ostroff looked at the agency’
FDA Policy/General
Federal Register Final rule: FDA is amending the biologics regulations by removing the Hepatitis C Virus (HCV) “lookback” requirements for review of historical testing records. These regulations expired on 8/24/15 due to the sunset provision provided under the regulation. To view this final rule, click here.