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FDA
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Physician Payment Sunshine Act: FDA Issues Revised Draft Guidance for…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FDA Draft Guidance: Providing Submissions in Electronic…
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled…
FDA: House Republicans Question Generic Drug Rulemaking Process
A large group of House Republicans is once against raising questions about the U.S. Food and Drug Administration's (FDA)…
FDA Social Media Guidance: Correcting Independent Third-Party…
The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate…
FDA Social Media Guidance: Presenting Risks and Benefits With Social…
The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate…
FDA Launches – Open FDA
In early June, the U.S. Food and Drug Administration (FDA) launched openFDA, a new initiative designed to make it easier…