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FDA
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The U.S. Food and Drug Administration (FDA) has notified Congress that it intends to issue draft guidance to propose a…
FDA Reliance on Draft Guidance for Significant Policy Changes under…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). …
FDA Guidance Balancing Premarket and Postmarket Data Collection for Devices
In releasing guidance entitled, "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket…
Physician Payment Sunshine Act: FDA Issues Revised Draft Guidance for…
The Affordable Care Act puts a lot of emphasis on transparency. Section 6002, the Physician Payments Sunshine Act,…
FDA to Conduct Study on Direct to Consumer Side Effect Information and the…
As recently noted, in 1997, pharmaceutical firms began advertising directly to consumers (DTC) via television ads, as a…
FDA CDRH Workshop on Future Guidance Documents
FDA's Center for Devices and Radiological Health (CDRH) sent a notice to industry, indicating that it is soliciting…
FDA Final Rule: Postmarketing Safety Reports for Human Drug and Biological…
FDA released a final rule amending postmarketing safety reporting regulations for drugs and biologics so those subject to…
FDA Draft Guidance: Providing Submissions in Electronic…
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled…