OR WAIT null SECS
October 05, 2006
Rockville, MD (Oct. 2)-The US Food and Drug Administration has issued its final Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations.
Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?
Rockville, MD (Sept. 28)-The US Food and Drug Administration has withdrawn three guidances for industry: ?Providing Submissions in Electronic Format?NDAs? (e-NDA), ?Providing Regulatory Submissions in Electronic Format?ANDAs? (e-ANDA), and ?Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.? These documents all recommend submitting information as portable document files (PDFs) or as SAS transport files.
September 07, 2006
Washington, DC (Sept. 1) - In a Federal Register announcement the US Food and Drug Administration laid out its guidance agenda for the coming months.
August 10, 2006
The US Food and Drug Administration has published a draft guidance, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC).
July 13, 2006
The US Food and Drug Administration today posted its final "Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format: Lot Release Protocols."
June 02, 2006
The US Food and Drug Administration (Rockville, MD) is withdrawing seven guidance documents "because some of the principles in these guidances are inconsistent with the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative) .
May 25, 2006
The CDER and CBER have released a new "Guidance for Industry: Q8 Pharmaceutical Development," outlining what drug manufacturers should include in the Pharmaceutical Development section of International Council on Harmonization (ICH) Common Technical Document (CTD) submissions.
January 12, 2006
FDA Issues Dispute–Resolution Guidance
November 03, 2005
New FDA Guidance on Electronic Common Technical Document Submissions