FDA releases draft guidance to outline standardized electronic study data format

When finalized, the guidance for industry “Providing Regulatory Submissions in Electronic Format – Standardized Study Data” will specify and implement electronic submission requirements for study data contained in NDAs, ANDAs, certain BLAs, and certain INDs. This guidance’s requirements will also be applied to Continue reading

Health Canada: Notice to Stakeholders – Amended Food and Drugs Regulations for Active Ingredients

Health Canada’s Health Products and Food Branch (HPFB) Inspectorate has notified stakeholders that Canada’s Food and Drug Regulations have been amended. The change extends Division 1A – Establishment Licensing and Division 2 – Good Manufacturing Practices (GMP) to active ingredients used in pharmaceutical drugs for human use Continue reading

FDA Provides Notice of Planned Withdrawal, Revision of Aged Guidance Documents

In September 2000, FDA issued the final rule “Administrative Practices and Procedures; Good Guidance Practices” (GGP). One aspect of the GGP regulation explains that the FDA will periodically review existing guidance documents to determine whether they need to be changed or withdrawn.

As such, the Center for Drug Evaluation and Research (CDER) has launched an initiative to review draft guidance documents published before 2010 in an effort to decide which guidances to withdraw, revise, or finalize Continue reading