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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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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

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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

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Congress Approves Agriculture, FDA Funding as Part of Consolidated Appropriations Act of 2015

FDA, Public Policy, USDA /

Congress has completed action on the Consolidated Appropriations Act of 2015 (the Act), which funds eleven of the twelve regular Appropriation bills through September 30, 2015, the balance of fiscal 2015.  Funding for the Homeland Security bill is provided under a Continuing Resolution through February 27.  The House approved the Act on Thursday, December 11,

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GMO Hearing

FDA, Public Policy /

Yesterday, the House Energy and Commerce Subcommittee on Health held a hearing to examine FDA’s role in the regulation of genetically engineered foods (commonly, but inaccurately, referred to as “genetically modified organisms” or “GMOs”).  Congressman Mike Pompeo’s (R-KS) Safe and Affordable Food Act (H.R. 4432), which would preempt state GMO labeling laws and require labeling only

GMO Hearing Read More »

Webinar Tomorrow: What Dispensers Need to Know About the Drug Supply Chain Security Act

FDA, Health Care, Public Policy /

A Complimentary Webinar Presented by OFW Law’s Tish Pahl and the Food Marketing Institute Thursday, December 4th, 2014 3:00 pm – 4:00 pm US/Eastern Please join FMI on a webinar with Tish Pahl —Under the Drug Supply Chain Security Act (DSCSA), beginning January 1, 2015, manufacturers, wholesaler drug distributors, and repackagers, must provide transaction data

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The DSCSA Standards Guidance is here!

1 Comment / FDA, Health Care, Public Policy /

This morning, FDA met another of its milestones in implementing the Drug Supply Chain Security Act (DSCSA) and posted a Draft Guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information.  FDA is to be commended for both getting the Draft Guidance

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FDA Shares the Pain in Final Rules on Menu Labeling and Vending Machine Food Labeling

1 Comment / FDA, Public Policy /

Citing the obesity epidemic and the fact that Americans consume about one-third of total calories in the form of foods prepared outside the home, FDA yesterday issued two sweeping  final rules on nutrition labeling of foods sold in chain restaurants and similar retail food establishments and vending machines. There had been considerable controversy over how

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Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part II)

FDA /

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 likely in the not so distant future.  These requirements were detailed in the draft guidance documents published on October 3 of this year, outlining

Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part II) Read More »

FDA Tweaks Its Guidance on Food Facility Registration

FDA /

FDA has released a revised guidance document on food facility registration: Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition).  The revised guidance adds only one new question and answer to the 34-page guidance: 1.3 Q: [Added November 2014] Under the supplemental notice of proposed rulemaking for preventive controls for human food,

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Consumer-Directed Promotions About Prescription Drugs: A Look Back at Print and TV Communications

FDA, Health Care, OFW Law News, Public Policy /

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part VI) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years.  Parts I, II, III, IV and V focus on

Consumer-Directed Promotions About Prescription Drugs: A Look Back at Print and TV Communications Read More »

GMPs Have Long History That Precedes Application In Medical Products

1 Comment / FDA, Health Care, OFW Law News, Public Policy /

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part V) By Neil P. Di Spirito In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years.  Parts I, II, III, and IV focused on

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26 Years, With 9 To Go…. 35 Years to Prescription Drug Traceability

2 Comments / FDA, Health Care, OFW Law News, Public Policy /

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part IV) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years.  Parts I, II, and III focused on Hatch-Waxman, medical

26 Years, With 9 To Go…. 35 Years to Prescription Drug Traceability Read More »

John Block Reports: Dietary Guidelines for Americans 2015 Edition – Losing It’s Way on Sugars (Part II)

FDA, Public Policy, USDA /

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block. There are a variety of disturbing questions surrounding the Dietary Guidelines for Americans now being drafted for release in 2015. The questions relate to whether the Dietary Guidelines Advisory Committee should focus its review and recommendations on the current science on nutrition

John Block Reports: Dietary Guidelines for Americans 2015 Edition – Losing It’s Way on Sugars (Part II) Read More »

John Block headshot

The Realized Benefits of User Fees

3 Comments / FDA, Health Care, OFW Law News, Public Policy /

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part III) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I and II focused on Hatch-Waxman and medical privacy laws, while

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FDA Public Meeting Will Consider Fundamental Changes to, and Expansion of, the Redbook

FDA /

By Mark L. Itzkoff In the October 30 Federal Register, FDA that it will hold a public meeting to receive public input on updating its commonly known as “the Redbook.” The meeting will be held on December 9. Requests to make oral comments during the meeting must be submitted to FDA by November 21, 2014.

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HIPAA Comes of Age… Thanks to HITECH, D.D.S.

4 Comments / FDA, Health Care, OFW Law News, Public Policy /

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part II) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights from throughout the years.  Part I focused on Hatch-Waxman.  Today’s blog focuses on the development

HIPAA Comes of Age… Thanks to HITECH, D.D.S. Read More »

Medical Devices, Pharmaceuticals and Food Products as Consumer Products – Additional U.S. and Canadian Regulatory Considerations

FDA, OFW Law News /

A Webinar Presented by OFW Law and Davis, LLP November 12, 2014, 1:00 p.m. EST During this webinar, attendees will learn about additional regulatory requirements placed on medical devices, pharmaceuticals, and food products as consumer products in the U.S. and Canada. Topics will include, among others: A general understanding of the interplay of obligations at

Medical Devices, Pharmaceuticals and Food Products as Consumer Products – Additional U.S. and Canadian Regulatory Considerations Read More »

Thirty Years of Hatch Waxman

4 Comments / FDA, Health Care, OFW Law News, Public Policy /

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part I) Since its inception in 1979, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practices have focused on myriad regulatory issues arising under FDA and broader HHS jurisdiction.  We advise clients on matters ranging from Hatch-Waxman and generic drug marketing exclusivity

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Ladd Wiley headshot

John Block Reports: Dietary Guidelines for Americans 2015 Edition – Losing It’s Way on Caffeine (Part I)

FDA, Public Policy, USDA /

This week, OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block. There are a variety of disturbing questions surrounding the Dietary Guidelines for Americans now being drafted for release in 2015. The questions relate to whether the Dietary Guidelines Advisory Committee should focus its review and recommendations on scientific advances in

John Block Reports: Dietary Guidelines for Americans 2015 Edition – Losing It’s Way on Caffeine (Part I) Read More »

Darren Webb headshot

How to Legally Import and Market Foods and Beverages in the U.S. and Canada

FDA, OFW Law News /

A Webinar Presented by OFW Law and Davis, LLP October 29, 2014, 1:00 p.m. EST During this webinar, attendees will learn about the regulatory requirements necessary to successfully and legally import and market foods and beverages in the U.S. and Canada. Topics for each country will include, among others: A general understanding of the regulatory

How to Legally Import and Market Foods and Beverages in the U.S. and Canada Read More »

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