Drug safety alerts almost double

Share this article:

An FDA report says the agency issued 68 drug safety alerts in 2011, an average of more than one each week and up 74% over the 39 alerts issued in 2010.

The report focuses on how FDA has been strengthening its drug safety science, citing efforts “to bring drug chemistry and pharmacology to bear on understanding drug safety.”

Under FDA's “equal voice” initiative, it has modified its reporting structure so the directors of CDER's Office of Surveillance and Epidemiology and the Office of New Drugs (OND) each report directly to CDER director Janet Woodcock—a change that “helped establish parity between these two important offices,” the report says.

In 2007, the FDA Amendments Act (FDAAA) gave FDA authority to require postmarket safety studies and clinical trials at the time of or after a drug's approval. FDAAA also let the agency require a change in a drug's label to include new safety information.

Since 2008, FDA has required new safety labeling 65 times, generally for whole classes of drugs. FDA published a draft guidance on implementing this authority in April 2011.

In CDER's Office of Generic Drugs (OGD) the agency established a postmarket surveillance and safety team within the Division of Clinical Review.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

Click the above link to access the complete Digital Edition of the October 2014 issue of MM&M, with all text, charts and pictures.

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets

Private View: New ways to engage with customers

Private View: New ways to engage with customers

These healthcare social media campaigns successfully use emotion, altruism and the human desire to "brand" oneself to get customers engaged.