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Guidelines
FDA to Study Disclosures in Prescription Drug Advertisements
The United States Food and Drug Administration (FDA) laid out plans in an August 9, 2018, Federal Register publication to conduct…
FDA Issues New Draft Guidance on Submitting Formal Meeting Requests
A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face,…
New Limitations on Guidance Documents Expected to Have Heavy Effect on…
The Trump Administration recently adopted new limits on the use of “guidance documents” issued by federal agencies. Various…
FDA Releases Guidance on IND Sponsors
In December, the FDA issued a guidance describing best practices and procedures for timely, transparent, and effective…
FDA Issues Two Federal Register Notices on Prescription Drug Promotion
On December 11, 2017, the United States Food and Drug Administration (FDA) published two Federal Register notices regarding…
FDA Issues Guidance on Real-World Evidence for Medical Devices
Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance on the use of real world evidence to…
FDA Releases Guidelines for Physicians Using Investigational Drugs in…
In a recent Manual of Policies and Procedures (MAPP), the FDA laid out the process by which physicians can access an…
FDA Offers Draft Guidance on E-Submissions of REMS Documents
The FDA recently released draft guidance describing how FDA plans to implement the requirements for the electronic submission of…
FDA Issues Draft Guidance on Biologic License Applications
The FDA recently released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the…
FDA Releases Draft Guidance for Industry: Statistical Approaches to…
The FDA announced a draft guidance for industry titled “Statistical Approaches to Evaluate Analytical Similarity”. The draft…