This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to establish prior notice. It communicates the agency’s position on a matter, but it does […]
Warning Letters Update Read More »
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 »
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FDA DRAFT Guidance: “Ensuring Safety of Animal Feed Maintained and Fed On-Farm” Read More »
On behalf of the Agriculture practice group at OFW Law, here is a copy of our Spring newsletter. We hope you find it useful. To receive this periodic newsletter by e-mail, please contact Carrie Morgan at cmorgan@ofwlaw.com.
Regulatory Round-Up Newsletter, Spring 2015 Read More »
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
2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy Read More »
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
The Vilsapp: Secretary Vilsack’s High Tech Solution to Labeling Read More »
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
Webinar: Drug Supply Chain Security Act Overview for Dispensers Read More »
We have blogged and hosted numerous webinars on FDA regulation of mobile medical apps (see here, here, here, here and here); but if you are an app developer, you should be aware that FDA is not the only agency looking at your app. The Federal Trade Commission (FTC) may also be watching how you promote your app. In fact, on February 23, 2015 the
Who Regulates the Advertising of Your App? Read More »
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
OFW Law Launches FDA DevicEd Training Initiative Read More »
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
FDA Announces National Kick-Off Meeting on FSMA Implementation Read More »
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 »
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
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)
Dr. Nina Fedoroff Joins OFW Law as Senior Science Advisor Read More »
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
CDRH’s 2015 Weather Forecast Predicts A Storm of Guidance Documents Read More »
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
114th Congress – What to Expect in Ag and Food Read More »
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 »
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 was certainly an interesting year to be involved in agriculture. We got to see supply and demand in full effect. Good weather sent grain prices tumbling while continuing tight supplies have kept cattle prices soaring. The Republicans made strong gains and will enter 2015 with control of both the House and Senate. While I
10 Things to Watch in 2015 Read More »
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 »
