FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Q3D(R1) Elemental Impurities.” The International Council for Harmonization-prepared document revises the existing guidance “Q3D Elemental Impurities” and provides an updated permitted daily exposure for the cadmium inhalation route of exposure. The updated PDE of 3 micrograms/day
FDA Policy/General
Federal Register notice: FDA has announced a 4/16 public meeting entitled “Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.” The meeting will be convened by Duke University’s Robert J. Margolis, Center for Health Policy (Duke-Margolis) under a cooperative agreement with FDA. It
FDA Policy/General
Federal Register notice: FDA has reopened the comment period indefinitely on a 4/3/2019 Federal Register notice seeking scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “510(k) Third Party Review Program.” The document provides a comprehensive look into FDA’s current thinking regarding the 510(k) Third Party Review Program. It discusses factors that will be used in determining whether a Class 1 or
FDA Policy/General
FDA said 3/10 it is postponing most foreign inspections through April due to the Covid-19 outbreak. An Alston & Bird FDA Compliance and Enforcement Advisory says that inspections outside the U.S. deemed to be “mission-critical” will be considered on a case-by-case basis. The advisory
FDA Policy/General
Federal Register notice: CDER has announced that it will begin supporting the Clinical Data Interchange Standards Consortium for Study Data Tabulation Model version 1.8 (SDTM v1.8), and CDISC Standard for Exchange of Nonclinical Data Implementation Guide — Animal Rule version 1.0 beginning 3/15. This means that these
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Providing Regulatory Submissions in Alternate Electronic Format.” The document addresses submissions (NDAs, BLAs, ANDAs, etc.) that are exempt from the requirement to submit electronically following the agency-recognized electronic common technical document format. It also describes an alternate electronic
FDA Policy/General
FDA commissioner Stephen Hahn was criticized during a House Appropriations subcommittee hearing 3/11 about delays in coordinating laboratory-developed tests amid the coronavirus outbreak. Subcommittee chair Sanford Bishop (D-GA) said he was worried about Hahn and the Trump Administration’s “confusing and inaccurate predictions” about how many coronavirus
FDA Policy/General
Federal Register notice: FDA has announced a 5/4 public workshop entitled “FY 2020 Generic Drug Regulatory Science Initiatives.” The workshop will provide a status update and seek public input on regulatory science initiatives for generic drugs. The agency and an opportunity for public input on these initiatives. Under the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 16 ANDAs from multiple applicants after they notified the agency that their drug products were no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control.” The document proposes to remove a previous recommendation that sponsors of all new therapies for Type 2 diabetes uniformly rule out risks for ischemic cardiovascular
FDA Policy/General
FDA has postponed foreign inspection of regulated products until May due to the coronavirus outbreak. “Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis,” FDA commissioner Stephen Hahn says in a release. The State Department has also issued travel restrictions and
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the current charter expiration date. The new charter will be in effect until 3/3/2022. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Guangzhou Tinci Materials Technology, Guangzhou, China (1/23): FDA inspected the company 7/29 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to use
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “FDA Safety Communication Readership Survey” (OMB Control Number 0910-0341). The CDRH surveys seek to evaluate the clarity, timeliness, and impact of safety communications from a sample of recipients. FDA says that understanding how the target audiences
FDA Policy/General
FDA and FTC have issued seven Warning Letters to companies for allegedly selling fraudulent coronavirus products. These products are unapproved drugs that pose significant risks to patient health and violate federal law. FDA says it is concerned that the products claim to cure, treat or prevent serious diseases like coronavirus,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment.” The document provides recommendations for characterizing topical drug product safety regarding the risk for contact dermatitis. The recommendations are directed toward development of topical new drug products
FDA Policy/General
Federal Register notice: FDA has reopened until 5/5 the comment period for a 11/7/2019 notice on a draft document entitled “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.” The document discusses risk-based principles that support ongoing FDA postmarketing safety surveillance for
FDA Policy/General
Federal Register notice: FDA has announced a 4/3 public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting aims to provide information and solicit public input on
FDA Policy/General
Draft Guide on Including Older Patients in Trials Federal Register notice: FDA makes available a draft guidance entitled “Inclusion of Older Adults in Cancer Clinical Trials.” 03/06/2020 Policy for Coronavirus Testing Labs Federal Register notice: FDA makes available a final guidance entitled “Policy for Diagnostics Testing in Laboratories
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Inclusion of Older Adults in Cancer Clinical Trials.” The document provides recommendations about including older adult patients in drug oncology clinical trials. It emphasizes the importance of including adults over age 75 years. The guidance also includes recommendations for
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.” The document describes a policy for laboratories using tests they develop