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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This morning, FDA met another of its milestones in implementing the Drug Supply Chain Security Act (DSCSA) and posted a Draft Guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing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  FDA is to be commended for both getting the Draft Guidance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  These requirements were detailed in the draft guidance documents published on October 3 of this year, outlining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

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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

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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,

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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

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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

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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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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 »

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

FDA /

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 subset of in vitro diagnostic devices known as Laboratory Developed Tests (LDTs) and the firms that produce them.

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

Roger Szemraj headshot

FDA To Hold Public Meeting on FSMA Supplemental Proposed Rules

FDA /

The Food and Drug Administration (FDA) has announced a public meeting to be held on November 13, 2014 to discuss its four supplemental proposed rules under the Food Safety Modernization Act (FSMA). On September 29, FDA published supplemental proposed rules for four of its “foundational” FSMA rulemakings: Produce Safety Preventive Controls for Human Food Preventive

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FDA Tweaks Its Four Foundational FSMA Proposed Rules

1 Comment / FDA /

FDA has published supplemental proposed rules for the four “foundational” rules that will implement the Food Safety Modernization Act (FSMA).  Those four rules are: Produce Safety; Preventive Controls for Human Food; Preventive Controls for Animal Food; and Foreign Supplier Verification Programs (FSVP). Comments on the supplemental proposed rules are due December 15, 2014. The “Supplementals”

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John Block headshot

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

FDA, OFW Law News /

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 successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among others:

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What to Do After I Filed My Comment on FDA’s Proposed “Nutrition Facts” Labeling Regulations

FDA, Public Policy /

Don’t sit back and wait: Be proactive! The comment period for FDA’s proposed regulations revising the “Nutrition Facts” label has closed.  The comment period has also closed for FDA’s proposed rule that would lead to more than 30 new serving sizes for foods.  This is a big deal because the nutrient content information that appears

What to Do After I Filed My Comment on FDA’s Proposed “Nutrition Facts” Labeling Regulations Read More »

Ladd Wiley 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 »

Darren Webb headshot

How to Legally Import and Market Medical Devices in the U.S. and Canada

FDA, OFW Law News /

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 successfully and legally import and market a medical device in the U.S. and Canada. Topics

How to Legally Import and Market Medical Devices in the U.S. and Canada Read More »

Export Certificates for FDA-Regulated Foods Containing Egg Products as an Ingredient

FDA, USDA /

The USDA’s Food Safety and Inspection Service (FSIS) plans, effective November 10, 2014, to halt issuing export certificates for FDA-regulated foods that contain an egg product(s) as an ingredient because USDA’s Agricultural Marketing Service (AMS) now provides this service. FDA regulates the safe production, sanitary processing, and labeling of food products containing egg products.  Nevertheless,

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GMA Announces Initiative to Address Criticisms of GRAS Exemption

FDA /

By Mark L. Itzkoff We have previously reported on criticism of the so-called “GRAS Exemption” and FDA’s GRAS Notification Program by the Pew Charitable Trusts, the Natural Resources Defense Council, and the Center for Science in the Public Interest.  In response to these criticisms, the Grocery Manufacturers Association (GMA) recently announced a 5-part initiative to improve

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FDA Updates 4 Proposed Rules Implementing FSMA

FDA /

The Food and Drug Administration (FDA) today made available proposed revisions to four (of seven) proposed rules implementing the FDA Food Safety Modernization Act (FSMA).  The proposed revisions address: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (for a summary, click here); Standards for the Growing, Harvesting, Packing, and

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Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada

FDA, OFW Law News /

Announcing OFW Law and Davis LLP’s New Four-Part Webinar Series: REGULATORY REQUIREMENTS FOR THE IMPORT OF MEDICAL PRODUCTS AND FOODS INTO THE U.S. AND CANADA OFW Law and Davis LLP have joined together to present a new webinar series to provide attendees with an overview of laws with which a firm must comply when importing

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Andrew Tsui headshot

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

FDA, OFW Law News /

A Webinar Presented by OFW Law and Davis, LLP October 15, 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 successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among

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

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