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FDA
Drug and Device Companies Critical Of FDA’s Guidance Development
Recently, the Combination Products Coalition ("CPC") wrote a letter to Leslie Kux, FDA's Assistant Commissioner for…
21st Century Cures Update: Ebola Hearing October 16, FDA’s LDT Draft…
This past July we wrote about the 21st Century Cures initiative and its efforts to bridge the gap between medical advances and the…
FDA Releases Cybersecurity Guidance: “Content of Premarket…
Late last week, the Food and Drug Administration released its “cybersecurity” guidance, outlining recommendations that…
FDA Reopens Comment Period For Social Media Guidance; PhRMA and Washington…
FDA is reopening the comment period for its two controversial draft social media guidances. The decision comes in response to…
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Recently, the US Food and Drug Administration (FDA) released a new draft guidance document on the content and format of…