FDA Policy/General
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 6/8 from 8 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
FDA Policy/General
Bipartisan Senate HELP Committee leaders have introduced legislation to help FDA and the National Institutes of Health (NIH) to “attract top talent during this exciting time in science.” The FDA and NIH Workforce Authorities Modernization Act also would authorize the two agencies to streamline coordination and cut red tape. A
FDA Policy/General
In her first interview since leaving her position as FDA commissioner, Margaret Hamburg says that one of the challenging things in her years on the job was that “we didn’t have a lot of advocates on the Hill. Often, even the White House really was a little bit suspect
FDA Policy/General
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 5/24, 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 the safety
FDA Policy/General
Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 5/11 from 1 p.m. to 4:30 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will participate
FDA Policy/General
A coalition representing research and policy organizations, producers, purchasers, and infectious disease doctors and scientists has written to the House and Senate Appropriations Committees calling for funding in the FY 2017 budget to support implementation of the National Action Plan for Combatting Antibiotic-Resistant Bacteria (CARB). The 3/16 letter
Drugs
Harvard Medical School professor Jerry Avorn raises objections to the loosening of First Amendment controls on what drug manufacturers are permitted to say about their products. Writing in a Health Affairs blog post, he says the “real issue is whether we as a society feel that there is something special
FDA Policy/General
Federal Register Notice: FDA is seeking comments on the final results of a study of the workload volume and full costs associated with the process for reviewing biosimilar biological product applications (final report). This study was conducted by an independent consulting firm, and it fulfills FDA’s statutory requirement under
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Electronic Submission of Medical Device Registration and Listing — 21 CFR Part 807, Subparts A Through D” 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 seeks comments on extending Office of Management and Budget approval on the existing recordkeeping requirements for this information collection on animal proteins prohibited in ruminant feed. Comments should be submitted b y 5/16. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined that the drug products listed in this document including Kenalog, Indocin, Bactrim and Bactrim Pediatric, and Nitropress were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve ANDAs that refer to the products as
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance: Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. It provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room
FDA Policy/General
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 5/5, 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.
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. alvSupplement Direct dba TJM Resale’s Synaptik Supplements & Ligand Solutions Saint Paul, MN (3/3). Reviewed the label for “Anhydrous Caffeine Bulk Powder” product. Also, in January FDA
FDA Policy/General
Federal Register Notice: FDA’s Office of Pediatric Therapeutics and CDER are announcing a two-day public workshop 4/13-14 entitled “Advancing the Development of Pediatric Therapeutics: Successes and Challenges of Performing Long-Term Pediatric Safety Studies.” Its purpose is for FDA to have an open discussion with experts
FDA Policy/General
Federal Register Notice: FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet 4/25, from 8 a.m. to 5:30 p.m. at the Park Marriott Hotel and Conference Center, Chesapeake Ballroom, 3501 University Blvd. East, Hyattsville, MD. This meeting is a reschedule of a postponed
FDA Policy/General
Federal Register Notice: CDER and the International Society for Pharmaceutical Engineering (ISPE) will co-sponsor the “Fifth Annual FDA-ISPE Quality Conference” 6/6-8. Its purpose is to discuss manufacturing, compliance, and management practices that create, implement, and sustain a culture of high quality and result in reliable pharmaceutical
FDA Policy/General
Federal Register Notice: FDA is making available for public comment the draft environmental assessment submitted by Oxitec Ltd. and a preliminary finding of no significant impact in support of an investigational release of OX513A Aedes aegypti genetically-engineered mosquitoes under an investigational new animal drug exemption. It is a part
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Implementation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009. It describes the agency’s approach to implementing the statutory provision under which an application for a biological
FDA Policy/General
Federal Register Notice: FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee will meet 5/3-4 at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committees will
FDA Policy/General
DEVICES Becton Dickinson has received FDA approval for its BD Totalys MultiProcessor and BD Totalys SlidePrep instruments for use in cervical cancer screening, as well as providing ancillary testing aliquot capability. FDA has approved Boston Scientific’s Blazer Open-Irrigated radiofrequency ablation catheter to treat Type I atrial flutter, an
FDA Policy/General
BIOLOGICS Guidance on HCT/P Donor Screening to Reduce Zika Virus Federal Register Notice: FDA is making available a document entitled Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry. It provides establishments that