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Draft guidance regarding self-identification of generic drug facilities and Q&A on generic drug user fee amendments

Reed Smith LLP
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USA
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September 6 2012

On August 27, 2012, FDA issued draft guidance documents for industry entitled "Self-Identification of Generic Drug Facilities, Sites, and Organizations" and "Generic Drug User Fee Amendments of 2012: Questions and Answers."

FDA final rule implementing device registration and listing requirements

Reed Smith LLP
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USA
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September 6 2012

The FDA issued a final rule in August amending current regulations to reflect recent statutory amendments to the device registration and listing provisions of the FD&C Act

FDA issues guidance for comment on refuse to accept policy for 510(k)s

Reed Smith LLP
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USA
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September 5 2012

On August 13, 2012, FDA released draft guidance for public comment entitled “Refuse to Accept Policy for 510(k)s.”

FDA establishes FY 2013 user fee rates for biosimilars and prescription drugs

Reed Smith LLP
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USA
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September 5 2012

The Food and Drug Administration (FDA) has announced the rates for biosimilar and prescription drug user fees for FY 2013

FDA guidance on FY 2013 medical device user fee small business qualification and certification

Reed Smith LLP
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USA
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September 5 2012

The FDA has issued guidance on FY 2013 medical device user fees for small businesses

FDA issues draft guidance regarding acceptance & filing review for PMA applications

Reed Smith LLP
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USA
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July 31 2012

FDA has announced the release of a draft guidance document concerning the necessary elements and contents of a complete premarket approval (PMA) application and the key decisions that are made during the filing process

FDA draft guidances describe product-specific bioequivalence recommendations

Reed Smith LLP
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USA
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July 16 2012

The FDA has released additional draft and revised draft product-specific bioequivalence (BE) recommendations

FDA proposes unique device identification system for medical devices

Reed Smith LLP
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USA
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July 16 2012

On July 10, 2012, in response to requirements in legislation that passed Congress with broad bipartisan support, the Food and Drug Administration published a proposed rule that would require most medical devices distributed in the United States to carry a unique device identifier, or UDI, except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device (e.g., devices sold over-the-counter and low risk devices

FDA draft guidance document on transferring clinical investigation oversight to another IRB

Reed Smith LLP
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USA
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July 16 2012

The FDA has published a notice announcing the availability of draft guidance on "Considerations When Transferring Clinical Investigation Oversight to Another IRB."

FDA small entity compliance guidance: toll free number labeling for drugs

Reed Smith LLP
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USA
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July 16 2012

The FDA has published a Small Entity Compliance Guide entitled "Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications."