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FDA
FDA Releases Guidance on IND Sponsors
In December, the FDA issued a guidance describing best practices and procedures for timely, transparent, and effective…
FDA REMS Blueprint on Opioids Finalized
On January 30, 2018, the United States Food and Drug Administration (FDA) finalized the “Opioid Analgesic REMS Education…
State of the Union De-Briefing
President Donald Trump gave his second State of the Union address this week, and while reactions to his speech were mixed, he…
E&C Health Subcommittee Votes to Advance Allowing Truthful Off Label…
Immediately before the government shutdown, the Energy and Commerce Health Subcommittee held a markup to advance three health care…
Gottlieb Announces Medical Device Approval Process Update
FDA Commissioner Scott Gottlieb announced in a blog post the agency would be updating its medical device approval processes in…
OPDP Letters Remain on Decline
The Office of Prescription Drug Promotion (OPDP) is known for monitoring company communications about medical products and when it…
FDA to Host Meeting on Opioid Prescribing Information Implementation
On January 30, 2018, the United States Food and Drug Administration (FDA) will host a public meeting entitled, “Opioid Policy…
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…