IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on providing recommendations on...more
2023 was a momentous year for psychedelics, and it’s not just because we at Budding Trends started writing about them. There were wins for the psychedelic industry at the local, state, and federal levels, as well as in the...more
When we think of compounding, which is the process of combining, mixing, or altering ingredients to create a medication specific to the needs of an individual patient, we think of the Cars’ 1978 classic, “It’s All Mixed Up.”...more
Under Section 3213 of Food and Drug Omnibus Reform Act, the U.S. Food & Drug Administration (“FDA” or the “Agency”) is required to establish the Advanced Manufacturing Technologies Designation Program, an initiative intended...more
The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more
Could Help to Streamline Development and Approval - On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more
The U.S. Food and Drug Administration (FDA) recently published the draft guidance “Sameness Evaluations in an ANDA – Active Ingredients,” which aims to assist applicants preparing an abbreviated new drug application (ANDA) by...more
On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will...more
In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more
On July 20th, the FDA released draft Guidance regarding its standards on therapeutic equivalence (TE) between both biologic and small molecule (NCE) drugs. The definition of "therapeutic equivalence" in the Guidance is...more
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more
Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more
On January 16, 2019, the United States Food and Drug Administration issued a new draft Guidance entitled “ANDA Submissions –Amendments and Requests for Final Approval to Tentatively Approved ANDAs”. This new FDA Guidance...more
The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this...more
The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more
On Friday, the FDA issued a draft guidance document intended to provide ANDA holders with information about how and when to propose any necessary labeling updates to their drugs when the reference-listed drug (RLD) upon which...more