FDA Releases New Study Format Validation Rules

The US Food and Drug Administration (FDA) has released a new document intended to provide a recommended approach for submitting study data for drugs and biological products using the Standard for Exchange of Nonclinical Data (SEND) standard.

FDA targets illegal online pharmacies in globally coordinated action

The U.S. Food and Drug Administration, in partnership with other federal and international agencies, took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers.  The FDA and the U.S. Customs and Border Protection (CBP) also conducted extensive examinations at U.S.-based international mail facilities, where many packages containing prescription drugs enter the U.S., and found that most of the examined packages contained illegal prescription drugs that had been ordered from online sources.

FDA approves first human papillomavirus test for primary cervical cancer screening

The U.S. Food and Drug Administration approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer in April.  The test also can provide information about the patient’s risk for developing cervical cancer in the future.

Study shows that the public does not trust FDA

JAMA Study Shows Deep Public Mistrust in FDA, Belief Agency is Suppressing Cures; A new study published in the Journal of the American Medical Association’s (JAMA) Internal Medicine portrays worrying information about public trust in the US Food and Drug Administration (FDA).

US FDA Scrutinizing 3-D Printing for Medical Devices

 US medical device market regulators are putting the burgeoning practice of 3-D printing for medical devices under the microscope, having announced a public workshop on the issue in October 2014 at the Food and Drug Administration’s headquarters.