The US Food and Drug Administration (FDA) has finalized its long sought-after guidance document on the use of its four expedited drug approval programs, including the recently instituted breakthrough product designation.
The total value of acquisitions in the medical device sector rose nearly 200% during the 1st quarter, with deal volume up more than 111% compared with Q1 2013, according to a PricewaterhouseCoopers report.
US and EU trade negotiators are reportedly hung-up over how—or if—to rely on the results of one another’s regulatory inspections of drug manufacturing facilities, threatening to derail part of the Trans-Atlantic Trade and Investment Partnership (TTIP), The Wall Street Journal reports.
SUMMARY: Public comments submitted to the US Food and Drug Administration (FDA) regarding its guidance documents are generally tame, referring to matters for preference or a need to clarify vague sections. But in the case of a recent response to a new guidance on distributing reprints of scientific and medical literature, one group’s message for FDA is a bit more confrontational: Make changes to the guidance—or else.
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.
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.
The U.S. Food and Drug Administration is looking to expedite the approval process for medical devices that would help patients whose urgent healthcare needs aren’t met by current technology.
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.
?The US Food and Drug Administration (FDA) conducts tens of thousands of inspections of pharmaceutical, medical device and biological manufacturing facilities each year, resulting in thousands of subsequent reports noting deficiencies.
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products.