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As part of the FDA’s ongoing efforts in their goal of more ANDA approvals in order to increase access to high-quality lower cost generic drugs, the agency began on 18 June 2019 to publish additional data in the existing Paragraph IV Patent Certifications list. The FDA hopes to assist ANDA applicants in their business decisions to pursue generic drug development. The list will now include, on a prospective basis, the following information:

  • Number of potential first applicants
  • 180-day decision status
  • Date of first “first applicant” approval
  • Date of first commercial marketing
  • Expiration date of last qualifying patent

For further information, please see the FDA’s Patent Certifications and Suitability Petitions website.

The FDA has posted a website regarding products containing cannabis or cannabis-derived compounds, and particularly cannabidiol (CBD), articulating their current position and 4 specific points they are working to learn more about. The webpage includes a link to a public docket the FDA is using to gather information and data. The docket is available for comment until 16 July 2019. The agency has consistently stated, however, that it believes that CBD is not a legal ingredient in a food or a dietary supplement because it has been investigated as a Investigational New Drug (IND) and has been approved for use in the drug Epidiolex.

Effective 17 June 2019, the FDA is making pre-assigned ANDA number requests available via the CDER NextGen Portal.

Guidance Document updates on the FDA website

CDER

CDER & CBER

CDRH

CDRH & CBER

  • Testing for Biotin Interference in In Vitro Diagnostic Devices
    This guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians.

CVM

Posted in Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices.