FDA Policy/General
Panel to Review OTC Meds for Upset Stomach/Hangovers Federal Register Notice: FDA has announced a 4/4 joint meeting of the Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss safety issues associated with over-the-counter analgesic combination products used
FDA Policy/General
Federal Register Notice: FDA has announced a 4/4 joint meeting of the Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss safety issues associated with over-the-counter analgesic combination products used for upset stomach (i.e., heartburn, nausea, fullness, belching,
FDA Policy/General
When President Trump told Congress 2/28 his first budget request will seek a 10% increase in defense programs and a 10% cut in non-defense discretionary programs, he put FDA at risk, says Alliance for a Stronger FDA deputy executive director Steven Grossman in his latest weekly analysis and
FDA Policy/General
Melayna Lokosky, a self-described corporate fraud expert and market analyst, who won a whistleblower case against Johnson & Johnson’s Acclarent unit, says that venture capitalists have no place running FDA. Writing in an online MedCity News opinion piece, Lokosky says that her experience is that “venture capitalists can
FDA Policy/General
Federal Register final rule technical amendment: FDA has amended the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogynecologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring
FDA Policy/General
Federal Register Notice: FDA has withdrawn approval of a new animal drug application and an abbreviated new animal drug application at the sponsors’ requests because the products are no longer manufactured or marketed. Products withdrawn are Baxter Healthcare Aerrane (isoflurane USP) and Hospira’s Ceftiofur (ceftiofur sodium) for injection. To
FDA Policy/General
Federal Register notice: FDA has confirmed the effective date of 2/23 for a direct final rule that removes an “essential use” designation for certain ozone-depleting substances (ODSs) under the Clean Air Act. The action removes the essential-use exemption for sterile aerosol talc administered intrapleurally by thoracoscopy for
FDA Policy/General
Several clinical research organizations have written the National Institutes of Health and National Library of Medicine urging them to engage FDA and other stakeholders to obtain recommendations for improving ClinicalTrials.gov. Medical product sponsors are required to register their trials and submit results information at ClinicalTrials.gov. According to the
FDA Policy/General
Federal Register notice: FDA has announced a 3/1 public workshop in Silver Spring, MD on the current state and further development of animal models for serious infections caused by Acinetobacter baumannii and Pseudomonas aeruginosa. The agency is conducting the workshop in order to facilitate the development of narrow-spectrum
FDA Policy/General
Xynomic Pharmaceuticals has acquired from Pharmacyclics the exclusive worldwide rights to develop, manufacture and commercialize Abexinostat, a potentially best-in-class innovative Pan-Histone Deacetylase Inhibitor designed to target hematological and solid tumors. To date a total of 14 Phase 1 and 2 clinical trials of Abexinostat in U.S.
FDA Policy/General
Putney ANDA for Mupirocin Ointment Approval Withdrawn Federal Register notification of withdrawal: FDA has at the sponsor’s request withdrawn approval of a Putney, Inc. ANDA for mupirocin ointment 2% because the product is no longer manufactured or marketed. To view the notice, click here. 20 New Animal Drug Approvals
FDA Policy/General
President Trump 2/24 signed an executive order requiring FDA and other federal agencies to “establish a regulatory reform task force, which will ensure that every agency has a team of dedicated — and a real team of dedicated people — to research all regulations that are unnecessary, burdensome and harmful to
FDA Policy/General
Federal Register notification of withdrawal. FDA has withdrawn approval of 18 new animal drug applications and two abbreviated new animal drug applications. The withdrawals involve antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed, and they are no longer manufactured or marketed.
FDA Policy/General
Arguing that the drug industry “is as heavily regulated as it gets,” APCO Worldwide president of health care and former FDA associate commissioner for public affairs Wayne Pines urged the Trump White House 2/24 to heed industry advice and spare the agency the brunt of its government-wide deregulation.
FDA Policy/General
Federal Register notification of withdrawal: FDA has at the sponsor’s request withdrawn approval of a Putney, Inc. ANDA for mupirocin ointment 2% because the product is no longer manufactured or marketed. To view the notice, click here.
FDA Policy/General
Former CDRH Division of Cardiovascular, Respiratory, and Neurological Devices acting deputy director Daniel Spyker has joined NDA Partners as an expert consultant. The product development and regulatory strategy firm says Spkyer’s “knowledge and expertise of cardiovascular, respiratory, and neurological devices at FDA and in the Industry, in addition to
FDA Policy/General
The Trump Administration is planning to submit its budget plan to Congress on 3/14. Capitol Hill Republicans told the Associated Press that they are expecting a skinny Trump blueprint with fewer details than usual because of the new administration changeover and short time new Office of Management and Budget
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Fenwal, Inc. Lake Zurich, IL (10/14/2016): CBER’s Advertising and Promotional Labeling Branch has reviewed Presentation slides to introduce InterSol Solution to blood collection facility staff submitted
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance entitled “Q11 Development and Manufacture of Drug Substances — Questions and Answers (regarding the selection and justification of starting materials).” The International Council for Harmonization guidance is intended to clarify the principles for selecting starting materials. It focuses on chemical entity
FDA Policy/General
Faster drug approvals and more medical device apps might be among the first issues tackled by former FDA deputy commissioner Scott Gottlieb if he is named commissioner, according to an Endpoints News analysis. The online post says that while other names are also being floated as possible commissioner candidates, Gottlieb
FDA Policy/General
Federal Register Notice: FDA has established a public docket to collect comments related to pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between 9/17/2016 and 2/24/2017 on the agency’s Web site, but will not be presented at a 3/6-7 Pediatric Advisory
FDA Policy/General
The U.S. District Court for the Western District of Louisiana has entered a consent decree against dietary supplement maker Pick and Pay Inc./Cili Mineral and its owner, Anton S. Botha, ordering the business to immediately cease operations until it comes into compliance with federal laws. A Justice Department