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FDA
Ivy Sports Medicine v. Burwell, et al.: FDA May Not…
FDA does not have “inherent reconsideration authority” to reclassify medical devices without notice and a comment…
FDA Releases Guidance Describing the Agency’s 510(k) Review Process
The Food and Drug Administration has released a guidance document that offers insight into their decision-making when reviewing…
Biosimilars Update: FDA Releases “Purple Book”; Two Companies File…
Vaccines, allergy shots, blood components, and gene therapies are examples of biological products. Most biologics are produced in…
PhRMA Proposes “Early Review” System for Reserving Proprietary Names to FDA
The Food and Drug Administration (FDA) recently invited public comment on plans to allow pharmaceutical companies to…
Senate Appropriations Committee “Concerned” That FDA Has Not…
As reported by The Hill, earlier this year, the Senate Appropriations Committee told the Food and Drug Administration…
FDA ANDA Submissions Content and Format of Abbreviated New Drug…
Recently, the US Food and Drug Administration (FDA) released a new draft guidance document on the content and format of…
Celgene Faces Off-Label Promotion Lawsuit Over Successful Cancer Drugs…
Since 2006, Celgene Corporation has earned $20.9 billion from the sales of two of its drugs—Thalomid and Revlimid. The drugs are…
FDA to Propose Oversight of Laboratory Developed Tests
The U.S. Food and Drug Administration (FDA) has notified Congress that it intends to issue draft guidance to propose a…
FDA Reliance on Draft Guidance for Significant Policy Changes under…
In May, Senator Lamar Alexander (R-TN), the ranking member of the Senate HELP Committee, along with Senators Richard…
FDA FDASIA Health IT Report
As reported, earlier this year, the Food and Drug Administration (FDA) released the FDASIA Health IT Report (Report). …