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FDA
FDA Issues New Set of Guidances Focused on Generic Drug Submissions and…
In late January 2022, the United States Food and Drug Administration (FDA) issued three guidances (two final and one revised…
OPDP Issued Six Letters in 2021
The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a total of six letters in 2021. Four were…
Califf Narrowly Voted by Senate to Be Next FDA Commissioner
Robert Califf was narrowly approved in the U.S. Senate and will return to the FDA as its next commissioner. With this in mind, we…
OPDP Sends “Bad Ad” Warning Letter over PARAGARD Video
On February 12, 2021, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a…
OPDP Sends Warning Letter to CytoDyn Over Promotional Video for Its IND…
On February 11, 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a…
Eli Lilly is the Recipient of the First OPDP Untitled Letter of 2022
On January 19, 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent an…
FDA Issues Two Draft Guidance Documents on Real-World Data
At the end of 2021, the United States Food and Drug Administration (FDA) issued two draft guidance documents that outline the…
Becerra Reinstates FDA Rulemaking Authority
On August 30, 2021, Health and Human Services (HHS) Secretary Xavier Becerra issued a Notice that reversed former HHS Secretary…
FDA Revises COVID-19 ANDA Guidance
In early September 2021, the United States Food and Drug Administration (FDA) revised its Development of Abbreviated New Drug…
CME/CNE/CPE Medical Education Program Helps Physicians Integrate the FDA…
Leading continuing medical education provider, Rockpointe, in conjunction with Boston University and Potomac Center for Medical…