<!– –> <!– Page Last Updated: 03/18/2011 –> Page Last Updated: 03/18/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Warning Letters 2011
<!– –> <!– Page Last Updated: 03/28/2011 –> Page Last Updated: 03/28/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors
    Safety Announcement Additional Information for Patients and Consumers Additional Information for Healthcare Professionals Data Summary Table of epidemiological studies evaluating fracture risk with proton pump inhibitors   Safety Announcement [05-25-2010] The U.S. Food and Drug Administration (FDA) is revising the prescription and over-the-counter (OTC) labels for a class of drugs called proton pump…
Clinical Investigator Inspection List (CLIIL)
<!– –> <!– Page Last Updated: 04/01/2011 –> Page Last Updated: 04/01/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Pediatric Exclusivity Granted
<!– –> <!– Page Last Updated: 03/31/2011 –> Page Last Updated: 03/31/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [03-29-2011] The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules. Due to the potential for product breakdown from moisture and loss of potency, Pradaxa capsules should only…
Current Drug Shortages
<!– –> <!– Page Last Updated: 04/01/2011 –> Page Last Updated: 04/01/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)
The Prescriber’s Role – Recognize and Report FDA’s educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading. The “Bad Ad” Program is administered by the agency’s Division of Drug Marketing, Advertising, and…
Newly Added Guidance Documents
<!– –> <!– Page Last Updated: 03/31/2011 –> Page Last Updated: 03/31/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.