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On November 8, 2023, the Food and Drug Administration (FDA) announced that it will be ready to accept registration and listing information for the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by the statutory deadline of December 29, 2023 and encourages companies to meet that deadline.
Following a lengthy period of anticipation, Health Canada has released Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format and sample files.
The US Food and Drug Administration (FDA) has recently made updates to forms 365h and 1571. Form 365h is “Application to Market a New or Abbreviated New Drug or Biologic for Human Use”. These applications are commonly referred to as NDA, ANDA or BLA. Form 1571 is “Investigational New Drug Application (IND)”. These are among the most important eCTD forms involved in your drug or biologic application process.
On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of information related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically, to assist persons submitting cosmetic product facility registrations and product listings to FDA.
Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
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