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FDA
FDA Finalizes Guidance to Help Regulated Industries with Voluntary Recalls
In early March 2022, the United States Food and Drug Administration (FDA) finalized guidance to help regulated industries (i.e.,…
FDA Requests Comments on Potential Modification to Opioid Analgesic Risk…
On April 21, 2022, the United States Food and Drug Administration (FDA) filed a Notice and Request for Comment regarding a…
FDA Publishes Guidance on Premarket Pathways for Combination Products
Earlier this year, the United States Food and Drug Administration (FDA) published a final guidance, “Principles of Premarket…
FDA Announces Proposed Recommendations for Fifth Reauthorization of Medical…
On March 22, 2022, the United States Food and Drug Administration (FDA) announced that the agency had reached an agreement with…
FDA Plans to Move Forward with Studies on Patient Understanding of…
In June 2021, the United States Food and Drug Administration (FDA) published a 60-day notice requesting public comment on the…
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…