AG/FDA Blog

Adverse Event Information Now Available Online for CFSAN-Regulated Products

FDA has begun posting online (and intends to update quarterly) information derived from adverse event reports the agency has received about conventional foods (including food/color additives), dietary supplements, and cosmetics.  This information is… Read More
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Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part II)

In our prior posting, we provided a brief overview of the notification and adverse event reporting requirements that will apply to the vast majority of a subset of in vitro diagnostic devices known as Laboratory Developed Tests (LDTs), most like… Read More
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Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part I)

On October 3 of this year, the Food and Drug Administration (FDA) published draft guidance documents that, when finalized, will mark a “game changer” for clinical laboratories. Specifically, these guidances call for the active regulation of a sub… Read More
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How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 15, 2014, 1:00 p.m. EST During this webinar, the second of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to succes… Read More
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How to Legally Import and Market Medical Devices in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 1, 2014, 1:00 p.m. EST During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfu… Read More
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How to Legally Import and Market Medical Devices in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 1, 2014, 1:00 p.m. EST During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfu… Read More
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FDA Final Rule and Guidance on Emergency Records Access

The Food and Drug Administration (FDA) has issued a final rule expanding its emergency records access authority, as provided by the Food Safety Modernization Act (FSMA).  Establishment, Maintenance, and Availability of Records: Amendments to Record… Read More
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Dietary Supplements: New Online Method Now Available for Reporting Serious Adverse Events

Industry may now use a new form, accessible on the Department of Health and Human Services’ (HHS) Safety Reporting Portal, to satisfy requirements for reporting to HHS (including FDA and the National Institutes of Health) any serious adverse event… Read More
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MDR Reporting of Foreign Adverse Events -- What is Your Obligation?

Under the U.S. Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) Regulation, 21 C.F.R. Part 803, medical device manufacturers must report adverse events involving their devices to FDA when information reasonably suggests that: Th… Read More
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Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong?

On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007 (“FDAAA”).  FDAAA both enhances and curtails FDA’s authority in many respects.  Specifically, FDAAA removes a r… Read More
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