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Guidelines
What Does the Consolidated Appropriations Act Mean to Industry?
On December 27, President Trump signed into law the Consolidated Appropriations Act, 2021, which was passed by Congress the…
Trump Administration Makes Final Proposed Rule Push
Two proposed rules from the last few weeks of the Trump administration may be of note to some of our readers. The first addresses…
FDA Issues Draft Guidance on Proprietary Names
The U.S. Food and Drug Administration (FDA) issued a pair of draft guidance documents aimed at guiding the selection of…
HHS ONC Releases Final Rule Implementing the Cures Act
On March 9, 2020, the United States Department of Health and Human Services (HHS) Office of the National Coordinator for Health…
FDA Releases Draft Guidance on Biosimilar Review
Earlier this month, the United States Food and Drug Administration (FDA) issued new draft guidance on how it plans to expedite its…
DEA Amends Regulations Applicable to Registrants Ordering Certain…
Last month, the Drug Enforcement Administration (DEA) published a notice in the Federal Register that it is amending its…
FDA Releases Two Draft Guidances on REMS Programs
On January 24, 2019, the United States Food and Drug Administration (FDA) released two draft guidances focused on improving the…
FDA Announces New Efforts to Hold Industry Accountable for Fulfilling…
On November 16, 2018, the United States Food and Drug Administration (FDA) announced that the agency plans to soon publish a…
Medscape Releases 2018 Ethics Report
Medscape recently released its 2018 Ethics Report, entitled “Money, Romance, and Patients.” To create the report, Medscape…
CDC Releases a Guide on Implementing Opioid Guidelines – But Is A Showdown…
On September 21, 2018, the Centers for Disease Control (CDC) issued a publication, “Implementing the CDC Guidelines for…