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FDA
Is There a Decrease in FDA Regulations?
According to an article in the Economist, FDA’s Commissioner Scott Gottlieb has overseen a fairly significant decrease in the…
FDA Transparency Blueprint Issued
Most everyone even tangentially related to the pharmaceutical industry knows and understands that right now,…
FDA announces Public Meeting on Evaluating Inclusion and Exclusion Criteria…
On April 16 from 8:30am to 5pm, the FDA will be holding a public meeting entitled “Evaluating Inclusion and Exclusion Criteria in…
FDA Issues New Draft Guidance on Submitting Formal Meeting Requests
A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face,…
Aegerion Sentenced to Pay $7.2 Million to Patients
On January 30, 2018, Federal U.S. District Court Judge William Young sentenced Aegerion to pay some of the roughly $36 million…
FDA Announces Study on Consumer and HCP Deception Perception
In December 2017, the United States Food and Drug Administration (FDA) announced plans to study whether consumers and healthcare…
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…