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Are You Ready for Electronic MDR Reporting?

FDA /

Paper medical device reports (MDR) will soon be a thing of the past.  On August 14, 2015, the electronic MDR final rule goes into effect, requiring manufacturers, importers and other firms responsible for reporting to submit MDRs to the FDA electronically through the agency’s Electronic Submission Gateway (ESG) rather than through paper forms, including discs or facsimiles. As detailed in FDA’s February 13, 2014, final rule on Electronic Medical […]

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John Block Reports: Let’s Keep A Strong Alcohol Section in the 2015 Dietary Guidelines

FDA, Public Policy, USDA /

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block: Today’s Quiz: What has more alcohol – a 12 oz can of beer? A 5 oz glass of wine? Or, a mixed drink with 1.5 oz of spirits? Answer – they all have the same amount of alcohol. 0.6 fl oz. With

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The White House Announces Plans to Update the U.S. Regulatory Framework for Biotechnology

EPA, FDA, Public Policy, USDA /

On July 2nd, the White House issued an executive memorandum on “Modernizing the Regulatory System for Biotechnology Products.”  The modernization effort will apply to “biotechnology products” defined as “products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes.”  It will not affect regulation

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Doom and Gloom: FSIS Provides Recommendations to Retailers on Listeria Control

FDA, USDA /

The Food Safety and Inspection Service (FSIS) has authority under the Federal Meat and Poultry Products Inspection Acts to ensure that products are not adulterated at retail and at all steps in the distribution chain. Retail operations are generally inspected by State or local authorities which have adopted some form of the model Food Code

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Device Firms: What You Should Know About The 21st Century Cures Act

FDA, Health Care, Public Policy /

Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and Commerce Committee by a vote of 51-0 on May 21.  Known as the 21st Century Cures Act (“Act”),

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FDA Releases Draft Guidance on Compounding Animal Drugs

FDA, Public Policy /

Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance).  The Federal Register notice accompanying the Draft Guidance can be found here.  The agency also withdrew its previous Compliance Policy Guide (CPG) 608.400, Compounding of Drugs for Use in Animals. Though FDA has been actively implementing Title

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Clearing Up Confusion: The Net Quantity of Contents Declaration on Food Labels

FDA /

By Robert A. Hahn The FDA’s food labeling regulations include some traps for the unwary.  A few of those traps have to do with the net quantity of contents declaration. Here are a couple of points to keep in mind when declaring a food product’s net contents: When the net contents declaration is expressed in terms

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Food Defense Plans

FDA, USDA /

By Barbara J. Masters, D.V.M. One of the goals of the Food Safety and Inspection Service’s Strategic Plan is to “ensure that facilities implement safeguards and systems to protect food from contamination by people who might try to intentionally and maliciously harm consumers.”  The Agency has a FY 2015 target of 90% of all establishments having a

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FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data

FDA /

By Mason Weeda FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States [(“OUS”)] (“Draft Guidance”) (available here). With this Draft Guidance, FDA aims to minimize the possibility for additional

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Food Facility Registration Rules To Be Updated by FDA

FDA /

FDA has published a proposed rule that would amend and update its regulatory requirements governing registration of food facilities. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which essentially directed FDA to take steps to protect the public from a threatened or actual terrorist attack on the U.S.

Food Facility Registration Rules To Be Updated by FDA Read More »

FDA DRAFT Guidance: “Ensuring Safety of Animal Feed Maintained and Fed On-Farm”

FDA /

In earlier blogs, I have mentioned having horses and other animals while growing up on a small farm.  Even now, to my husband’s dismay, I have never outgrown being “horse crazy.”  But during all this time, I never remember being concerned about the animal feed I have purchased or used.  I do qualify this statement

FDA DRAFT Guidance: “Ensuring Safety of Animal Feed Maintained and Fed On-Farm” Read More »

2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy

FDA, Health Care, Public Policy, USDA /

The 2015 Dietary Guidelines Advisory Committee (DGAC) submitted its report to the Secretaries of Agriculture and Health and Human Services last month and disbanded.  It is now up to the USDA and HHS to take the DGAC’s conclusions and recommendations and issue a revised edition of the Dietary Guidelines for Americans.  Interested persons may submit

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The Vilsapp: Secretary Vilsack’s High Tech Solution to Labeling

FDA, Public Policy, USDA /

By Marshall L. Matz, as published in Agri-Pulse The March edition of the National Geographic Magazine, in its cover story entitled “The War on Science,” notes that “there’s no evidence that GMO’s are harmful to human health.” A recent Pew poll found that 90% of all scientists believe GMO’s are safe but only 37% of the public

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Webinar: Drug Supply Chain Security Act Overview for Dispensers

FDA, Health Care, Public Policy /

On April 21, OFW Law’s Tish Eggleston Pahl will participate in a webinar being held by the Healthcare Distribution Management Association (HDMA) for dispensers on implementation of the Drug Supply Chain Security Act (DSCSA) Register Today! Learn what is expected of dispensers as it relates to the DSCSA through a HDMA webinar on Tuesday, April 21 from 2:00–3:00

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OFW Law Launches FDA DevicEd Training Initiative

FDA, OFW Law News /

OFW Law is proud to announce the launch of its FDA DevicEd Training Initiative.  The initiative is devoted to providing high quality FDA regulatory training to foreign and domestic medical device companies and the advisors who assist them.  Interactive in-person seminars will be developed and presented by OFW Law attorneys specializing in FDA regulation of

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FDA Announces National Kick-Off Meeting on FSMA Implementation

FDA /

FDA will hold a “National Kick-Off Meeting on Implementation of the Food Safety Modernization Act (FSMA)” on April 23-24, 2015, in Washington, D.C. The agency has sent out a save-the-date notice to subscribers to its FSMA webpage, but the notice contains few details.  FDA says that meeting specifics, including registration information, will be made available

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Drug Supply Chain Security Act – What’s Next? A whole lot.

FDA, Health Care, Public Policy /

The passage of the Drug Supply Chain Security Act (DSCSA) in November 2013 led to a very busy 2014 as FDA and manufacturers, wholesale distributors, and dispensers began the statute’s complex 10-year implementation.  2015 promises to be equally busy. A Surge Of Activity At Year-End In 2014 2014 closed in a flurry of DSCSA action. 

Drug Supply Chain Security Act – What’s Next? A whole lot. Read More »

FDA Decides Not to Actively Regulate Medical Device Data Systems, Medical Image Storage Devices, Medical Image Communication Devices and Similar Mobile Medical Apps

FDA /

There is good news for certain sectors of the medical device industry.  FDA has decided not to actively regulate medical device data systems (MDDS), medical image storage devices, medical image communication devices and similar mobile medical applications (apps).  In a pre-published Federal Register notice (available here, which should issue in the Federal Register on Monday), FDA

FDA Decides Not to Actively Regulate Medical Device Data Systems, Medical Image Storage Devices, Medical Image Communication Devices and Similar Mobile Medical Apps Read More »

Dr. Nina Fedoroff Joins OFW Law as Senior Science Advisor

FDA, OFW Law News, Public Policy, USDA /

We are pleased to announce that Dr. Nina Fedoroff, a renowned plant molecular biologist, has joined OFW Law as Senior Science Advisor focusing on agriculture policy, global food security and government affairs.  The former Science and Technology Adviser to the Secretary of State, Dr. Fedoroff has long been involved in regulatory issues surrounding genetic modification of organisms (GMOs)

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CDRH’s 2015 Weather Forecast Predicts A Storm of Guidance Documents

FDA /

Earlier this month, FDA’s Center for Devices and Radiological Health issued its FY 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance.  CDRH lists 28 guidance documents in total.  The “A-list” includes both draft and final guidances that CDRH intends to publish by January 2016, and the “B-list” includes guidance documents that it intends to

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114th Congress – What to Expect in Ag and Food

EPA, FDA, Public Policy, USDA /

As the 114th Congress begins in earnest, there is rough sledding ahead this winter over the gulf between the governing philosophies of the President and the new Congress. Not to belabor the obvious, but early indications are that Republican victories have altered the President’s willingness to deal only very modestly, if at all.  With just

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A Flurry of End-of-Year Activity from FDA on Food

FDA, Public Policy /

In what seemed like a bit of end-of-year housekeeping, FDA issued a series of minor guidance documents, notices, and other regulatory paraphernalia related to food.  Coming in under the wire in 2014 were: A notice requesting nominations for non-voting industry representatives to the Food Advisory Committee. Nominations are due by January 7, 2015.  FDA is

A Flurry of End-of-Year Activity from FDA on Food Read More »

2014 And 2015

FDA, Public Policy, USDA /

As we say goodbye to 2014 and welcome 2015, it’s time for a little backward and forward looking. Here’s what we saw in the 2014 rear view mirror in our little corner of the Universe devoted to the regulatory aspects of foods, drugs, medical devices, agriculture, and the like. In January, the Food and Drug

2014 And 2015 Read More »

The Raw Milk Debate

FDA /

Recently, with the ahead-of-print release of the Center’s for Disease Control’s (CDC) study, “Increased Outbreaks Associated with Nonpasteurized Milk, United States, 2007–2012” which will be published in January in the Emerging Infectious Diseases journal, there have been numerous articles and blogs supporting each side of the raw milk issue – that it is the “best

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FDA Announces New Surveys of Foodborne Illness Risk Factors in Restaurants, Retail Food Stores, and Foodservice Institutions

FDA /

FDA has published notices announcing that, over the next 10 years, it plans to conduct surveys on the occurrence of foodborne illness risk factors in restaurants, retail food stores, and foodservice institutions (e.g., hospitals, schools). Pursuant to the Paperwork Reduction Act, FDA is required to provide a 60-day notice of a proposed collection of information

FDA Announces New Surveys of Foodborne Illness Risk Factors in Restaurants, Retail Food Stores, and Foodservice Institutions Read More »

Fred Branding headshot

FDA’s Draft Guidance On DSCSA Preemption Misses The Mark

FDA, Health Care, Public Policy /

In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA). FDA, the pharmaceutical supply chain, and other stakeholders have been working very hard to implement the DSCSA as quickly as

FDA’s Draft Guidance On DSCSA Preemption Misses The Mark Read More »

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