FDA Policy/General
After a 24-year career, FDA Division of Import Operations director Domenic J. Veneziano has left the agency to join international trade and regulatory law firm Sandler, Travis & Rosenberg as an independent FDA regulatory and strategic consultant. In his new role, Veneziano will provide advice to producers, importers, exporters
FDA Policy/General
Several public health groups have petitioned FDA asking that it withdraw approval of the use of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes. Antibiotic sales to the livestock industry have grown in recent years, despite the agency’s request for the industry to
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Pharmacy of Illinois, Inc. (dba Alwan Pharmacy and Compounding Center) Peoria, IL (7/22). FDA investigator inspected drug compounding operation and observed serious deficiencies in its practices for
FDA Policy/General
Federal Register notice: FDA has released a guidance on “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” The document provides establishments that make donor eligibility determinations for donors
FDA Policy/General
FDA is looking for public input on its efforts to mitigate antimicrobial resistance by focusing for the first time on medically important antimicrobials used to treat human disease that are placed in animal feed or water that have at least one therapeutic indication without a defined duration of use. A
FDA Policy/General
Federal Register notice: FDA has released a guidance on “Qualification of Biomarker — Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease (COPD).” The document provides a qualified context of use for plasma fibrinogen in COPD interventional clinical trials for patients at
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register notice: FDA has released a draft guidance on “510(k) Third Party Review Program” that provides current thinking and proposes to harmonize with elements from the International Medical Device Regulators Forum’s regulatory assessment program called the Medical Device Single Audit Program. In addition, it describes criteria to
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee. The committee advises the agency in discharging responsibilities related to the regulation of tobacco products. The committee also reviews and evaluates safety, dependence, and health issues relating to tobacco products and
FDA Policy/General
BIOLOGICS Blood Products Panel to Meet Federal Register Notice: FDA will hold a meeting of the Blood Products Advisory Committee 11/17 from 8 a.m. to 5:30 p.m. and 11/18, from 8:30 a.m. to 1 p.m. at FDA White Oak Campus, 10903 New
FDA Policy/General
Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Health Document Submission Requirements for Tobacco Products. It is intended to assist persons making certain document submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act. The revised draft guidance includes guidance
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled E17 General Principles for Planning and Design of Multi-Regional Clinical Trials. It was prepared under the auspices of the International Council for Harmonization. Multi-regional clinical trials (MRCTs) conducted according to the guidance will investigate treatment effects in
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Blood Products Advisory Committee 11/17 from 8 a.m. to 5:30 p.m. and 11/18, from 8:30 a.m. to 1 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center,
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Science Advisory Board to the National Center for Toxicological Research (NCTR) 11/1, from 8 a.m. to 5:30 p.m., and 11/2, from 8 a.m. to 11:40 a.m. at the Crowne Plaza Hotel, 201
FDA Policy/General
Federal Register Final rule: FDA is amending 21 CFR 17.2 to remove the maximum civil money penalties table associated with statutory provisions authorizing civil money penalties under the FD&C Act or the Public Health Service Act. This information will be included in the HHS regulations. The agency
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information “Postmarket Surveillance — 21 CFR Part 822,” 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 seeks comments on recordkeeping requirements related to the medical devices current good manufacturing practice quality system regulation. The CGMP/QS regulation includes requirements for purchasing and service controls, clarifies recordkeeping requirements for device failure and complaint investigations, clarifies requirements for verifying/validating production processes and process
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the charter of the Oncologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 9/1/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined that Prevacid IV (lansoprazole) intravenous injection, 30 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow the agency to approve ANDAs for lansoprazole intravenous injection, 30 mg/vial, if all other legal and regulatory requirements are
FDA Policy/General
Critics say that the FDA Office of Criminal Investigations invests thousands of hours pursuing foreign imported, mislabeled drugs, but too often the cases do not result in prosecution. A lengthy Reuters investigative report finds that prosecutors decline to pursue many FDA cases, citing a lack of prosecutorial merit, criminal intent,
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Requests for Clinical Laboratory Improvement Amendments of 1988 Categorization — 42 CFR 493.17,” 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 seeking comments on the information collection requirements for agency regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice. Comments should be submitted