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FDA
FDA Releases Draft Guidance on IND Submissions for Individualized Antisense…
Earlier this year, the United States Food and Drug Administration (FDA) issued draft guidance surrounding investigational new drug…
Industry Seeks Clarity on Interchangeability for BsUFA III
Towards the end of last year, the United States Food and Drug Administration (FDA) opened a public docket to solicit comments on…
FDA Releases Final Guidance Under GDUFA II
In mid-December 2020, the United States Food and Drug Administration finalized updated guidance to generic drug manufacturers. The…
FDA Issues Draft Guidance on Proprietary Names
The U.S. Food and Drug Administration (FDA) issued a pair of draft guidance documents aimed at guiding the selection of…
OPDP Sends Six Warning and Untitled Letters in 2020 – Final Letter Sent to…
At the end of November 2020, the Office of Prescription Drug Promotions (OPDP) sent its sixth – and final – letter of the year to…
FDA Finalizes Guidance Regarding Complex Products Meetings
Late last year, the United States Food and Drug Administration (FDA) finalized a guidance entitled, “Formal Meetings Between FDA…
FDA Releases Draft Question and Answers Guidance on Interchangeable…
In late 2020, the United States Food and Drug Administration (FDA) issued a draft set of four questions and answers guidance that…
CDRH Releases List of FY 2021 Priority Guidance Documents
Recently, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced a list…
OPDP Director Tom Abrams Retires
In October of this year, Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) Director Tom Abrams…
FDA Announces End of Unapproved Drugs Initiative
On Friday, November 20, 2020, the United States Food and Drug Administration (FDA) announced it would end the Unapproved Drugs…