OTC Monograph Order Request (OMOR) Fee Rates for Fiscal Year 2024 Announced by FDA
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2023, the USFDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft guidance on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C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.
On November 8, 2022, the CDE issued a notice on “Questions and Answers for Dissolution Profile Studies ⟨Technical Guidelines for Pharmaceutical Change Studies of Marketed Chemical Drugs (Trial) ⟩”
On December 2022, a new template Drug Export Sales Certificate has been launched, which conforms to the format recommended by the World Health Organization (WHO). Electronic certificates have the same effect as paper certificates.
On September 8,2022, FDA published the draft of a guideline that provides recommendations on the labeling of OTC drugs.
FDA publishes product-specific guidance’s to facilitate generic drug development.
Drug companies must submit an abbreviated new drug application (ANDA) to FDA for approval to market a generic drug.
THE US-FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain
FDA published FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain.
On May 2022, the FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product
Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are eight cannabis products approved by ANVISA.
Beginning on March 25, 2022, the FDA will be adding a unique quick response (QR) code to electronic Certificates of Pharmaceutical Products (eCPPs)