Tag Archive: in vitro diagnostics

Apr 11

New FDA Guidances for March 2013

FDA released several interesting new guidances last month, including several regarding communications with the FDA. Types of Communication During the Review of Medical Device Submissions is in accordance with the MDUFA III goals and includes descriptions of acceptance review communications, substantive interactions, interactive review, and missed MDUFA decision communications. Formal Meetings Between the FDA and Biosimilar …

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Dec 06

FDA’s New Guidances for November 2012

Several new guidance documents were released by FDA in November 2012, covering a wide range of subjects.  The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug …

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Dec 06

FDA's New Guidances for November 2012

Several new guidance documents were released by FDA in November 2012, covering a wide range of subjects.  The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug …

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Apr 09

New FDA Guidances Released in March 2012

Here’s a list of the notable guidances released by FDA in March 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program (Draft) Drug Safety Information — FDA’s Communication …

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Feb 20

New FDA Guidances – December 2011/January 2012

Here’s a list of the notable guidances released by FDA in December 2011 and January 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. December 2011 FDA Portable Document Format (PDF) Specifications (Updated) (More info on this guidance can be found in this previous blog post) The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications …

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Aug 08

New FDA Guidances Released in July 2011

Here’s a list of the guidances released by FDA in July 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device In Vitro Companion Diagnostic Devices (Draft) Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems Mobile …

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Jul 18

New Guidances from FDA – June 2011

Guidance

Here’s a list of the guidances released by FDA in June 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Q11 Development and Manufacture of Drug Substances (Draft) Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Draft) Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics (Draft) …

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Jun 10

New Guidances from FDA – May 2011

Here’s a list of the guidances released by FDA in May 2011 (along with a couple that were released inthe first week of June), compiled by Cato Research Regulatory Scientist Cathy Anderson. Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions (Draft) Financial Disclosure by Clinical …

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Jan 14

FDA Guidances – December 2010

Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in December 2010, including a few from the first week of January 2011 as well (links go directly to PDF documents).

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Dec 15

FDA Guidances – November 2010

Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in November 2010 (links go directly to PDF documents).

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