US FDA Extends Deadline for MoCRA Complaince
On November 8, 2023, the U.S. Food and Drug Administration (FDA) announced its intention to extend the enforcement deadline for cosmetic product facility registration and listing requirements as established by the Cosmetic Modernization Regulation Act of 2022 (MoCRA). The six-month extension is intended to provide industry with additional time to comply with the required facility registration procedures and provide detailed information on cosmetic products, thereby ensuring a smooth transition to the new regulations.
US FDA Publish Additional Condition for Nonprescription Use (ACNU)
On June 2022, the FDA introduced a new regulation aimed at establishing criteria for over-the-counter drugs that carry an Additional Condition for Nonprescription Use (ACNU). This initiative seeks to expand the range of drugs that the FDA could authorize for over-the-counter use.
US FDA publishes Permanent Accreditation System Conformity Assessment Program
In September 2023, the US FDA issued regulatory updates, to the guidance on the Innovative Devices Program and preliminary guidance on medical devices associated with weight loss.
OTC Monograph Order Request (OMOR) Fee Rates for Fiscal Year 2024 Announced by FDA
OTC Monograph Order Request (OMOR) Fee Rates for Fiscal Year 2024 Announced by FDA
Mexico’s Cofepris medical Device and IVD Registration and Approval in Mexico
GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.
Mexico’s Cofepris has Issued New Guidelines for Changes to Medical Device Registrations
In August 2023, Mexican regulators have updated guidance on rules for modifications to medical device registrations that could streamline COFEPRIS reviews.
UPDATES ON FDA COSMETIC REGISTRATION IN USA UNDER MOCRA 2022
On August 7, 2023, FDA issued a draft guidance that explains the requirements of facilities registration and products listing with the FDA under the Modernization of Cosmetic Regulations Act 2022 (MOCRA).
US FDA Releases Food Allergen Labeling
In May 2023, the U.S. Food and Drug Administration issued five more final orders completing the process of publishing different monographs as part of the over the counter (OTC) monograph reform under the Act CARES.
US FDA releases 5 New Over the Counter (OTC) Monographs (final orders)
In May 2023, the U.S. Food and Drug Administration issued five more final orders completing the process of publishing different monographs as part of the over the counter (OTC) monograph reform under the Act CARES.
The US FDA releases Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products & API
On April 2023, the USFDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft guidance on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act” that helps to prevent and mitigate drug shortage.
The US FDA’s To produce new Cosmetic Platform and Registration Requirements for Cosmetics (MoCRA)
On March 27, 2023, The Food and Drug Administration (FDA) also referred to as ‘The Agency’ announced they will no longer accept submissions into the Voluntary Cosmetic Registration Program (VCRP).
Mexico’s Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.
On February 13, 2023, COFEPRIS released Communicate No. 15/2023, a press communicating, their strategic alliance with the US FDA in the 2023. The strategy discusses primarily, The guarantee of the safety, quality, and efficacy of medicines in Mexico and the United States. Secondly, That Both authorities work on food safety for the benefit of the health of the populations of both nations.