FDA releases a proposed rule on biologics license applications and master files The FDA issued a proposed rule to amend its regulations relating to the use of master files for biological products. As per the requirements of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), marketing applications for biological products that previously could
FDA to provide new data regarding eligibility for 180-day exclusivity. The FDA enhanced their Paragraph IV Patent Certifications list in efforts to improve approval times for generic drug applications, this past week. The Paragraph IV Patent Certifications list contains relevant information to eligibility for 180-day exclusivity for generic drug products for those who have submitted a substantially complete abbreviated new drug application (ANDA)
Implementation of CDRH’s New Office of Product Evaluation and Quality. This week the FDA announced the official implementation of the Office of Product Evaluation and Quality (OPEQ) within the FDA’s Center for Devices and Radiological Health (CDRH). OPEQ has been established as a key step for the CDRH during the current period of reorganization. The
Unique Device Identification Program: The FDA Finalizes Guidance for Convenience Kits! FDA finalized the guidance, “Unique Device Identification: Convenience Kits,” which describes the FDA’s interpretation of the definition of “convenience kit” for purposes of applying unique device identifier (UDI) requirements only. This guidance does not apply to in vitro diagnostic (IVD) devices that are subject
CBD Update Last week, the outgoing FDA commissioner, Scott Gottlieb, announced that his agency will be using “enforcement discretion” to target products containing cannabidiol (CBD) that are making ‘over-the-line’ claims on their products. Gottlieb defines ‘over-the-line’ claims as claiming to cure cancer or prevent Alzheimers or other diseases. These claims could mislead a patient to
FDA & CBD: Looking forward The FDA has announced plans to hold a public meeting next month (April 2019) for the creation of “an appropriately efficient and predictable regulatory framework for regulating cannabidiol (CBD) products,” including food and supplements, Commissioner Scott Gottlieb said during testimony before the House Appropriations Committee. This is hopeful news for
Upcoming Changes to GUDID Grace Period! The FDA has announced that it plans to make changes to the GUDID grace period to return to the original seven day grace period. These changes are scheduled to be released beginning in March 2019. According to the original GUDID Guidance released, the GUDID Device Identifier (DI) record grace
Nonbinding Feedback After Certain FDA Inspections of Device Establishments. When a company is issued a FDA-483 List of Observations, at the close of an inspection of their operations, the consequences of not implementing a timely and most importantly, proper corrections can put the company in a precarious situation. If FDA is not satisfied with how
FDA Issues Final Guidance: Immunogenicity Testing of Therapeutic Protein Products Last week, the FDA released a final guidance document entitled, “Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection”. This final guidance is based on a draft guidance issued in April 2016 and the comments received during the industry
FDA OPERATIONS IN THE MIDST OF US GOVERNMENT SHUTDOWN. With the US Government shutdown-showdown continuing into its 3rd week, we took a closer look at the operations of Food and Drug Administration (FDA) during this period. According to a statement posted on the FDA website, agency operations continue to the extent permitted by law such
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