In Vitro Diagnostics Market Set to Grow to $74.7B by 2020
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.
FDA to Put Almost $38 Million Behind Effort to Improve Clinical Trials
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.
FDA Finalizes Expedited Product Guidance With Hundreds of Major, Minor Changes
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.
Report: Deals in the medical device sector rose 200% in Q1
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, EU Officials in Tangle Over Mutual Reliance on Drug Facility Inspections: 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.
Legal Group to FDA: Reprint Guidance Violates First Amendment, Existing Court Order
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.
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 eyes fast-track approval for urgently needed medical devices
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.
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.