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FDA Announces Meeting Intended to Start Standardization Process for REMS

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US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a Read More...

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ETASU

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Pharmaceutical Industry to FDA: Build Flexibility into GAIN Act

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When legislators passed a sprawling piece of legislation known as the Food and Drug Administration Safety and Innovation Act (FDASIA), they considered a huge range of problems facing both the US Food Read More...

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Qualifying Pathogens

Long-Awaited Guidance on CDRH's Appeals Process Released, Alleviating Some Industry Concerns

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The US Food and Drug Administration (FDA) has released two long-awaited guidance documents regarding the appeals process to be used by medical device manufacturers that have received a rejection by Read More...

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Regulatory Reconnaissance (16 May 2013)

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: Special Edition Dirty Medicine: The Epic Story of Criminal Fraud at Ranbaxy (Fortune) Read More...

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FDA Looking to Improve the Generic Drug Regulatory Process, Wants Industry Input

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The US Food and Drug Administration (FDA) plans to hold a public meeting in June 2013 to discuss its progress in advancing regulatory science for generic drug products and solicit feedback on its Read More...

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pharmaceutical

Regulatory Science

FDA Looks to Industry for Help as it Considers Massive Overhaul of 510(k) Process

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US regulators are preparing to revisit a now-withdrawn draft guidance on the clearance of medical devices through the 510(k) premarket notification pathway, and are looking for industry's help in Read More...

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Meta Complaints: FDA Says Complaints to CDRH Lack Common Structure, New Standard Needed

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The US Food and Drug Administration (FDA) is preparing to overhaul the way it receives concerns and complaints about the way in which it regulates and approves medical devices, saying the complaint Read More...

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Interview: FDA's UDI Architect Jay Crowley on the Agency's Approach to UDI and Pending Changes

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The US Food and Drug Administration (FDA) is, like many device regulatory bodies around the world, preparing to implement a huge overhaul of its medical device systems. Known as the Unique Device Read More...

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Jay Crowley

medical device

Traceability

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Unique Device Identification

Unique Device Identifier

Interview: FDA's James Valentine Explains why the Agency's New Patient Network is so Important

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The US Food and Drug Administration (FDA) recently set out to get patients and patient groups considerably more involved in the regulatory process through its Patient Network, a new website and Read More...

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Deborah Autor, One of FDA's Top Regulatory Officials, Leaving Agency

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The US Food and Drug Administration (FDA) announced today that one of its top regulatory officials, Deborah Autor, deputy commissioner for the office of Global Regulatory Operations and Policy (GO), Read More...

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Deborah Autor

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Mylan

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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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In Unprecedented Shift, EU Parliament Proposes Premarket Authorization for Medical Devices 15 April 2013
Goodbye, KFDA: Korean Regulator Gets New Name, Decentralized Authority After Reorganization 28 March 2013
FDA Gets Go-Ahead for Study of DTC Advertising and Social Media 18 April 2013
UPDATED: President's Budget Proposal Calls for Small Increases at FDA, but Big Changes for Industry 11 April 2013
IBM Awarded Huge Contract to Modernize Regulatory Review Processes at FDA 29 April 2013
New FDA Document Clarifies IND Process for Drugs, Biologics and Biosimilars 30 April 2013

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