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Latest News | 25 February 2014

CDER Seeks Someone to Head up its Regulatory Policy Development Office

US pharmaceutical regulators in the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) are looking to hire a new executive to head up its Office of Regulatory Read More...


Latest News | 25 February 2014

House Legislators Gear Up to Directly Challenge FDA's Generic Drug Labeling Rule

House legislators will soon hold a hearing on their and industry's "concerns" about the US Food and Drug Administration's (FDA) recent proposal to change the way generic drug labels are updated in Read More...


Latest News | 25 February 2014

Regulatory Reconnaissance: Judge: Regulatory Non-Compliance is Not a False Claim (25 February 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org. Do you work in regulatory Read More...


Latest News | 24 February 2014

FDA Says it Wants to Make Anticoagulants, Opioids and Diabetes Drugs Safer for Patients

The US Food and Drug Administration (FDA) wants to fund studies that will help it increase the safety of pharmaceutical and biological products even after they've been approved, it has Read More...


Latest News | 24 February 2014

FDA Adopts ICH Guideline on Transmission of Adverse Event Reports

US regulators have released the International Conference on Harmonisation's (ICH) E2B(R3) guideline on transmitting individual case safety reports (ICSRs) electronically, bringing the US into Read More...


Latest News | 24 February 2014

US Health IT Officials Call for Integration of FDA's Unique Device Identification with eHealth Records

The Office of the National Coordinator (ONC), a US health technology implementation advocate, has announced a new proposed rule that would advocate for the integration of the US Food and Drug Read More...


Latest News | 24 February 2014

FDA: China Still Withholding Promised Visas Meant to Bolster Inspectional Capacity

Late last year, US officials announced what they said was a breakthrough for the US Food and Drug Administration's (FDA) efforts to ramp up its inspection presence in China—a region with increasing Read More...


Latest News | 24 February 2014

Regulatory Reconnaissance: FDA to Quietly Begin Major Generic Drug Testing Effort (24 February 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org. Do you work in regulatory Read More...


Latest News | 21 February 2014

Senator Calls out Federal Health Officials Over Contradictory FDA, CMS Policies on Health Information

Late last year, the US Food and Drug Administration (FDA) made headlines by sending a Warning Letter to direct-to-consumer (DTC) genomics testing company 23andMe alleging that its flagship testing Read More...


Latest News | 21 February 2014

New Guidance Provides Framework on How to Keep a Drug the Same over Time

A new draft guidance document released by the US Food and Drug Administration (FDA) is meant to clarify the analytical procedures and methods used to validate the production of drugs and biological Read More...


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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more


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