News

Latest News | 30 May 2013

Draft Guidance Calls for Lengthier Premarket Safety Databases for Rheumatoid Arthritis Treatments

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The US Food and Drug Administration (FDA) has published a new draft guidance document regarding the development of pharmaceutical and biological products meant to treat rheumatoid arthritis, a painful Read More...

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Latest News | 28 May 2013

New FDA Guidance Recommends Use of Quality Agreements to Define Contract Responsibilities

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The US Food and Drug Administration (FDA) has released a new draft guidance regarding contract manufacturing arrangements, establishing the responsibilities of each entity involved in the manufacture Read More...

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Latest News | 21 May 2013

Industry Slams Device Recall Guidance, Highlighting Perceived Flaws

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The medical device industry is weighing in on a recent guidance document published by the US Food and Drug Administration (FDA), in several instances calling it deeply flawed and in need of Read More...

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Latest News | 16 May 2013

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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Latest News | 16 May 2013

FDA Provides Guidance on Use of Electronic Health Data, Pooled Data in Postmarketing Studies

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A new guidance document released by US federal regulators aims to establish best practices for conducting and reporting pharmacoepidemiologic safety studies that are conducted using electronic Read More...

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Latest News | 10 May 2013

FDA Adopts Expedited Blood Donation Screening Standard

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The US Food and Drug Administration (FDA) has released a final guidance document that it says is intended to expedite the donation of blood and plasma for frequent donors.BackgroundThe final guidance, Read More...

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Latest News | 24 April 2013

Final FDA Guidance to Reduce Regulatory Burdens for Updated IVDs

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A new guidance document just published by the US Food and Drug Administration (FDA) is intended to present a "least burdensome regulatory approach" for sponsors of class III in vitro diagnostic Read More...

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Latest News | 17 April 2013

Antibiotics must be Manufactured Separately from Penicillin, FDA Says

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The US Food and Drug Administration (FDA) has just published a new guidance document that finalizes its manufacturing framework for the production of many antibiotics.BackgroundFDA closely regulates Read More...

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Latest News | 12 April 2013

FDA Finalizes Guidance on Device Classification Procedures

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The US Food and Drug Administration (FDA) has released a new guidance document finalizing its recommendations for the medical device industry on how to use Classification Product Codes (CPC), a Read More...

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Latest News | 11 April 2013

New FDA Guidance Details Self-Selection Studies Used in Support of Nonprescription Drug Products

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A new final guidance document issued by the US Food and Drug Administration (FDA) provides recommendations for the pharmaceutical industry on how to develop and conduct self-selection studies in Read More...

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