FDA releases draft of guidance on drug-safety issues
The FDA's Center for Drug Evaluation and Research released a new draft guidance on how it develops and classifies drug-safety issues.
The FDA’s Center for Drug Evaluation and Research (CDER) released a new draft guidance on how it develops and classifies drug-safety issues.
The guidance, Drug Safety Information – FDA’s Communication to the Public, describes how CDER communicates emerging drug-safety information.
“In recent years, CDER has begun making information on potential drug risks available to the public earlier – often while the Center is evaluating safety data and determining whether any regulatory action is warranted,” according to a statement from CDER.
The guidance indicated that post-marketing safety issues will be tracked by CDER if they have the potential to lead to:
Withdrawal of FDA approval of a drug; limitations on a use in a specific population or subpopulation.
Additions or modifications to the Warnings and Precautions or Indications sections of the labeling Medication Guide, or other patient package insert.
Other risks.
In addition to the methods FDA already uses to communicate drug-safety issues, the agency is exploring: concise advisories and other Internet postings; more detailed short articles; articles in trade and professional journals; and a standardized, 1-document solution for patient medication information.
CDER also further clarified its Drug Safety Communication, a tool used to communicate important safety information about marketed drugs.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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