Last week, FDA released for comment a draft guidance titled Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers. FDA guidances are nonbinding recommendations without force of law, and this is only a draft. Nonetheless, it addresses a frequent and important problem in our industry.Continue Reading FDA Releases Draft Guidance on Responding to Internet Hogwash
The FDA recently published its Final Guidance on REMS programs for prescription drugs, which we thought might interest our readers. The document is formally called “Format and Content of a REMS Document: Guidance for Industry” and you can download and review the Final Guidance here. You might be thinking two things at this moment:
Having worked in the federal government, we are familiar with how important Department of Justice Guidance Policy memoranda can be. They set priorities, outline criteria for acceptable guilty pleas and sentencing factors, and can make a huge difference in terms of who gets indicted or sued for what, when, and under which circumstances. These DOJ