FDA Policy/General
FDA has posted a draft guidance on the “Use of Electronic Health Record (EHR) Data in Clinical Investigations.” The document provides recommendations on deciding whether and how to use EHRs as a source of data in clinical investigations, and their interoperability with electronic systems supporting clinical investigations. It also discusses
FDA Policy/General
FDA continues to be concerned with the same top inspectional findings repeating every year during drug and device inspections, CDER Office of Product Quality acting branch chief Andrea Chamblee told the Food and Drug Law Institute’s annual meeting in Washington, DC 5/12. For example, the top inspectional findings
FDA Policy/General
DEVICES Comments Extended on GMPs for Hearing Aids Federal Register Notice: FDA is extending the comment period to 6/30 for the document entitled “Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop,” that appeared in the 1/7 Federal Register. FDA requested comments on the appropriate level
FDA Policy/General
FDA has posted a guidance on “Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification.” The FDA Critical Path Initiative identified the discovery, characterization, qualification, and use of biomarkers as important for improving medical product development efficiency and success rates, the document notes. “The type of
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Food Labeling; Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. FDCA 403(r)(6) and its implementing
FDA Policy/General
Federal Register Notice: The FDA commissioner renews that charter of the Pulmonary-Allergy Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/30/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers. It provides recommendations to assist industry in designing studies to establish the analytical and clinical performance characteristics of infectious disease next
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Frequently Asked Questions About Medical Foods; Second Edition. This guidance provides responses to additional questions on the definition and labeling of medical foods and updates some prior responses. To download this guidance, click here. To view this notice,
FDA Policy/General
HHS general counsel Bill Schultz has announced his resignation from the department. Before joining HHS, he was a partner at Zuckerman Spaeder. Schultz has also previously served as Department of Justice deputy assistant attorney general, and FDA deputy commissioner for policy. Before joining FDA, he served as counsel to the
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the information collection provisions of abbreviated new animal drug applications (ANADAs). The information required to be submitted as part of an ANADA is described in FDCA 512(n)(1). Among other things, an ANADA is required to contain information to show
FDA Policy/General
Federal Register Notice: FDA will hold a public meeting 6/10 to gather stakeholder input on the potential development of a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user-fee program would provide funding to supplement congressional non-user-fee appropriations, and would support
FDA Policy/General
Federal Register Final rule: FDA is issuing a final rule to require that the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient submit an annual report to the agency. This report would include the amount of each such ingredient in the
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Technical Considerations for Additive Manufactured Devices. The agency has developed this draft leapfrog guidance to provide its initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. To
FDA Policy/General
Federal Register Notice: FDA is making available a revised guidance for industry entitled Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Small Entity Compliance Guide' for the final user fees rule published 7/10/14 and for the
FDA Policy/General
Federal Register Final rule: FDA is issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act. To view this notice, click here.
FDA Policy/General
Federal Register Final rule: FDA is issuing this final rule to deem products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the FD&C Act, as amended the Tobacco Control Act. This final rule also prohibits the sale
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hartley Medical Center Pharmacy, Inc. Long Beach, CA (4/21). Inspected 6/29-7/8/15. CGMP violations, unapproved new drug products, adulterated, misbranded: Investigators noted that the firm
FDA Policy/General
FDA has finalized a rule that revises the annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in animals intended for human consumption. Under the revised rule, companies are now required to provide estimates of sales broken down by major food-producing species in addition
FDA Policy/General
Federal Register Notice: FDA plans a public workshop 6/30 on clinical trial design considerations for malaria drug development. It is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of the
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Tobacco Product Master Files. It provides recommendations to industry on tobacco product master files (TPMF), which are voluntary submissions used to permit the person that owns the TPMF to authorize other parties to rely on information in the
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements; Small Entity Compliance Guide. It is intended to set forth in plain language the requirements of the
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems. Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA’s final rule deeming these products to be subject to