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 […]
The Raw Milk Debate Read More »
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
In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA).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FDA’s Draft Guidance On DSCSA Preemption Misses The Mark Read More »
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,
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
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
Webinar Tomorrow: What Dispensers Need to Know About the Drug Supply Chain Security Act Read More »
While you were sitting in traffic, making pie crust, or absorbing the menu and vending labeling rules… FDA Opens Portal For Wholesale Distributor and 3PL Reporting At OFW Law, we hope you all had a terrific Thanksgiving. (If you followed the advice of our food safety expert, Dr. Barb Masters, there should not have been
FDA Opens Portal For Wholesale Distributor and 3PL Reporting Read More »
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
The DSCSA Standards Guidance is here! Read More »
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
FDA Shares the Pain in Final Rules on Menu Labeling and Vending Machine Food Labeling Read More »
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 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,
FDA Tweaks Its Guidance on Food Facility Registration Read More »
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
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
GMPs Have Long History That Precedes Application In Medical Products Read More »
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 »
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
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
The Realized Benefits of User Fees Read More »
Phil: Rick, it’s hard to believe that 35 years have passed since we started this firm as a two-lawyer shop in 1979. Rick: It sure is. I remember working with you at the law firm I joined fresh out of the University of Michigan Law School, and which you had joined several years earlier out
Phil Olsson and Rick Frank on 35 Years of Life at OFW Read More »
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,
FDA Public Meeting Will Consider Fundamental Changes to, and Expansion of, the Redbook Read More »
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 »
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
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
Thirty Years of Hatch Waxman Read More »
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
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 »
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 »
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
FDA To Hold Public Meeting on FSMA Supplemental Proposed Rules Read More »
By Mark L. Itzkoff On October 20, 2014, FDA and the consumer group called the Center for Food Safety (CFS) filed a consent decree in the U.S. District Court for the District of Columbia that requires FDA to promulgate a final rule regarding the GRAS Notification (GRASN) Program by August 31, 2016. The decree resolves a
Settlement Agreement Reached on GRAS Notification Program Final Rule Read More »
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”
FDA Tweaks Its Four Foundational FSMA Proposed Rules Read More »
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:
How to Legally Import and Market Pharmaceuticals in the U.S. and Canada Read More »
By John R. Block, as published in the Des Moines Register Every day millions of shoppers are paying out as much as 50 or 100 percent more to buy organic foods for themselves and their families. I have friends who make these choices because they have no reason to question claims on labels, in advertising and
Consumers are Misled About Organic Safety Read More »
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
FDA has announced that its Risk Communication Advisory Committee (RCAC) will be holding a public meeting on November 3-4, 2014, at its White Oak Campus in Silver Spring, MD. The RCAC meeting will focus on messages about the importance of eating adequate amounts of fish and shellfish, while avoiding certain varieties with higher amounts of
Risk Communication about Methylmercury in Seafood Read More »
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 »
It is October 1st and time to renew your food facility registration(s) with FDA. Facilities (domestic and foreign) engaged in manufacturing, processing, packing, or holding food (human or animal) for consumption in the United States must register with FDA, unless exempt. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
FDA Food Facility Registrations Must Be Renewed Soon Read More »
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 »
Happy Birthday, Hatch-Waxman! You’re a mature 30-year old now, a regular adult. Some personal musings on my stroll down the Hatch-Waxman Memory Lane over the past 30-plus years follow. A small background digression: For those of you in the FDA regulatory arena who are real newbies or who have been in a Rip Van Winkleoid
Hatch-Waxman Turns 30 – A Stroll Down Memory Lane Read More »
