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FDA
Gottlieb Discusses Opioids and Lays Out Vision
On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse…
OPDP Sends First Untitled Letter of 2018
Here we are…barely finished with the first quarter of 2018, and the United States Food and Drug Administration (FDA) Office of…
FDA Plans to Review Promotional Research
According to new releases from the FDA, it plans to look at several issues related to biopharma advertising and promotion. FDA is…
Gottlieb Discusses Opioids and Lays Out Vision – Google it’s…
On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse…
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FDA Issues New Draft Guidance on Submitting Formal Meeting Requests
A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face,…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…