FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hanbul Cosmetics Co. Republic of Korea (3/29): FDA inspected the firm 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm could not provide
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Highly Concentrated Caffeine in Dietary Supplements.” FDA considers some dietary supplements that consist of only or primarily pure or highly concentrated caffeine to be adulterated, and the document outlines the agency’s current thinking on such products. It is intended
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products 21 CFR 310.306, 314.81(b)(3)(iii), and 600.82” (OMB Control Number 0910-0759). Agency regulations require application holders to notify FDA
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases.” The document provides recommendations for designing, developing, and establishing analytical performance for NGS-
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics; Guidance for Stakeholders and Food and Drug Administration Staff.” The document describes how publicly accessible databases of human genetic variants
FDA Policy/General
Panel to Review Siga Tech Smallpox NDA Federal Register notice: FDA announces a 5/1 Antimicrobial Drugs Advisory Committee meeting to discuss a Siga Technologies NDA for tecovirimat. 04/13/2018 Info Collection Extension on Dispute Resolution Federal Register notice: FDA submits for OMB approval an information collection extension for
FDA Policy/General
Federal Register notice: FDA has announced a 5/1 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Siga Technologies NDA for tecovirimat for the proposed indication of treating smallpox disease caused by variola virus in adults and pediatric patients. The product was developed under the agency’
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for its “Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice” (OMB Control Number 0910-0563). FDA regulations direct it to have adequate dispute resolution procedures to provide
FDA Policy/General
Federal Register notice: FDA has submitted to OMB for approval an information collection extension for “Notification of the Intent To Use An Accredited Person Under the Accredited Persons Inspection Program” (OMB Control Number 0910-0569). The notification is part of FDA’s voluntary third-party inspection program applicable to manufacturers
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.” The International Council for Harmonization addendum provides updates to the original 2000 guidance and it does not alter the scope of the original guidance, which outlines an approach
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 18 ANDAs from multiple applicants. The ANDA holders have notified the agency that the drug products are no longer marketed and requested that their approval be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 5/4 Reagan-Udall Foundation annual public meeting to discuss its activities and how it supports the agency. The meeting will include a panel discussion on the “Evolution of FDA Science and Engagement” and the role of the Foundation. To view the notice,
FDA Policy/General
Federal Register notice: FDA is seeking the participation of consumer organizations in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels. The agency is also requesting nominations for voting and nonvoting consumer representatives to serve the panels. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Petition To Request an Exemption From 100% Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR 111.75(a)(1)(ii)” (OMB Control Number 0910-
FDA Policy/General
Federal Register notice: FDA has announced several product approvals that redeemed a priority review voucher. The agency has determined that the following approved drugs met voucher redemption criteria: Sanofi’s Praluent (alirocumab) approved 7/2015; Sanofi’s Soliqua (insulin glargine and lixisenatide) approved 11/2016; and ViiV Healthcare’s Juluca
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. South Texas Botanicals Beeville, TX (3/29): FDA inspected the firm 10/2017 and cited the firm’s product labeling that promotes several of its dietary supplements that cause
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Class 2 Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300” (OMB Control Number 0910-0633). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.” The document discusses how early in drug development pediatric patients should be incorporated when evaluating systemic drugs for atopic dermatitis. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” The document discusses ethical and scientific issues when considering the inclusion of pregnant women in clinical trials involving drugs and biological products. It is intended to advance scientific
FDA Policy/General
Federal Register notice: FDA is requesting comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of five drug substances Cannabis plant and resin; extracts and tinctures of cannabis; delta- 9-tetrahydrocannabinol (THC); stereoisomers of THC; and cannabidiol. Comments received will
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension related to its regulation on “Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices” (OMB Control Number 0910-0577). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for its “Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” (OMB Control Number 0910-0701. To view the notice, click here.