By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc. Is your company still using paper batch records to manufacture your commercial products? In 2024, there are many affordable solutions to help improve accuracy, reduce...
FDA published draft guidance providing information regarding quality considerations for ophthalmic drug products consistent with the current good manufacturing practice (CGMP) requirements. This guidance revises the draft guidance issued in October 2023. This revision...
FDA launched a new search function on FDA’s Office of Pharmaceutical Quality webpage to improve access to drug quality resources and web content. The new search page scans existing FDA guidance documents, manuals of policies and procedures (MAAPs), and compliance...
This draft guidance outlines FDA’s current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA’s expectations for the reviews of 510(k) submissions and EUA...
FDA is issuing this draft guidance to inform industry about the agency’s continued use of remote evaluations as an approach for evaluating drug facilities, as appropriate. This guidance articulates the specific conditions that both the facility and FDA should meet...
