WEBFeb 22, 2021 · The US Active Pharmaceutical Ingredient Infrastructure: The current state and considerations to increase US Healthcare Security “Keeping the Nation’s drug supply chain secure, robust, and resilient is essential for the national security and economic prosperity of the United States1.” I. Summary
WEBSep 24, 2013 · Senior representative. Opening meeting (no fixed agenda) Rapid progress to manufacturing area. If supplier, assess contracts, procedures and specifications. Closing meeting. If supplier, LM phone attendance. What to Expect on the Day of the Audit.
FDA Issues Final Rule on Intended Use | 2021-08-02 | FDAnews
WEBAug 3, 2021 · The FDA yesterday issued a long-awaited final rule on the agency’s current practices in evaluating whether a product is intended for use as a drug or device. The final rule, which goes into effect on Sept. 1, is largely unchanged from the proposed rule the agency issued Sept. 23, 2020 (DID, Sept. 28, 2020). The finalized rule clarifies that a ...
FDA Launches New Webpage to Search for Documents on …
WEBJanuary 9, 2024. Drugs Quality Regulatory Affairs. The FDA launched a new search function on its website, designed to help users search for pharmaceutical quality-related guidances, compliance programs and manuals of policies and procedures (MAPP).
FDA Finalizes Guidance on Postapproval CMC Changes
WEBThe FDA has finalized guidance on post-approval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH). The harmonized guidance is designed to help drugmakers better manage CMC changes in their quality systems, which could lead to a reduced need for regulatory …
FDA Publishes Guidance on Oct. 1 eStar Requirement | FDAnews
WEBOctober 6, 2023. In a final guidance published by CBER and CDRH, the FDA provides updated standards for premarket notification (510 (k)) submissions by electronic format and establishes Oct. 1 as the start date for use of the revised standard. The guidance is part of the FDA’s commitment to the development of electronic submission templates ...
FDA Hopes to Resume On-Site Inspections by September
WEBMay 7, 2021 · The FDA said that it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September. In a new report, the agency outlined projections on how it could return to a more normal schedule of inspections based on three pandemic scenarios – most likely, best case and …
FDA Final Guidance on Glycerin, High-Risk Drug Components
WEBMay 9, 2023 · FDA Final Guidance on Glycerin, High-Risk Drug Components Aims to Prevent Poisonings. May 9, 2023. Drugs Regulatory Affairs. The FDA has issued a final guidance to help manufacturers prevent the use of glycerin and other high-risk drug components contaminated with the toxic substances diethylene glycol (DEG) or ethylene …
FDA Approves Single-Dose Vial Presentations of Comirnaty
WEBAug 30, 2022 · The FDA has approved Pfizer and BioNTech’s single-dose 0.3 mL vial version of its COVID-19 vaccine Comirnaty for individuals 12 years and older. The vaccine was previously only available in multiple dose vials, which presented some challenges for administering doses and leading to some wastage. The multiple-dose vials come in two …
FDA Draft Guidance Outlines Risk-Based Software Assurance for …
WEBSep 13, 2022 · Manufacturers ready to establish a risk-based framework for computer software assurance throughout the software’s lifecycle now have a clearer place to start. Today the FDA published a draft guidance with recommendations on software assurance for computers and automated data processing systems used in device production or …