Lori A Carr Last year, antibiotic-resistant infections caused more than two million illnesses and 23,000 deaths in the U.S. alone, according to the Centers for Disease Control. About 70 percent of those antibiotic-resistant infections were caused by hospital-acquired infections.
Senator Seeks Transparency in Medical Device Pricing
A new report predicts that the global in vitro diagnostics market will grow to $74.7 billion by 2020 fueled by increased awareness and demand for equipment that speeds up accurate diagnosis.
The US Food and Drug Administration (FDA) plans to pour as much as $37.5 million into an initiative intended to improve the quality of clinical trials, the agency has announced.
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.