News & Insights

My Mobile Medical Application Will be Regulated by FDA…What Do I Do Now?

October 17, 2013

Recently, FDA finalized its guidance on Mobile Medical Applications (MMA), which is available here. The release of this guidance document...

OFW Law News

Ken Ackerman’s Latest History: Abraham Lincoln’s Spoiled Son

October 17, 2013

How hard was it for Robert Todd Lincoln-oldest son of the great president who won the Civil War, ended slavery,...

EPA

Citizen Suit Goes Down The Drain in Farm Tile Case

October 16, 2013

Farm tile drains are not a point-source of pollution under the Clean Water Act, even if the outflows contain contaminated...

Public Policy

Bienvenue Aux Etats-Unis!

October 10, 2013

With so many of our respected friends and colleagues furloughed, federal agency budgets decimated, or wholly dependent on user fees...

Public Policy

Universities Salute World Food Prize Commitment to Sound Science & Biotechnology

October 9, 2013

As I mentioned last week, a major coalition of farm, food and anti-hunger organizations joined 30 institutions of higher education...

USDA

Building the Relationship

October 8, 2013

In a time when there is an information vacuum, I would encourage all meat and poultry establishment operators to “build...

USDA

Is Livestock Causing Climate Change?

October 7, 2013

“Livestock matters to climate change. The sector contributes 7.1 gigatonnes (giga=billion) CO2-eq (equivalent) to global anthropogenic GHG emissions – a...

Health Care

HHS Guidance Expands Scope of Refill Reminders and Reasonable Costs

October 3, 2013

As we reported recently, the Department of Health and Human Services (HHS) announced its intent to issue guidance regarding prescription...

Public Policy

Major Coalition, including Academia, Commends World Food Prize for Supporting Biotechnology

October 1, 2013

A very broad coalition of 100 food and agriculture organizations, including 30 research universities and anti-hunger organizations, have sent a...

USDA

The Phone Call that Comes Too Late

September 30, 2013

At least once a month, our USDA or FDA practice group receives that phone call…the phone call that comes from...

Public Policy

It Is “That” Time of Year

September 26, 2013

No, it is not time to face the Christmas shopping crowds, the kids have their back to school supplies, and...

USDA

Livestock & Meat Groups Want COOL Relief Pending WTO Review

September 25, 2013

On Monday, a group of trade associations representing the spectrum of America’s beef and pork production system issued an urgent...

FDA

FDA’s GRAS Review Process for Foods May Be Tested by Litigious Public Interest Group

September 12, 2013

By Bruce Silverglade and Mark L. Itzkoff As reported in Politico this week, there has been a shake-up of sorts...

FDA

MDR Reporting of Foreign Adverse Events — What is Your Obligation?

September 12, 2013

Under the U.S. Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) Regulation, 21 C.F.R. Part 803, medical device manufacturers...

Health Care

HITECH First Amendment Challenge Delayed – HHS Promises Guidance and Agrees to Limited Enforcement Delay

September 12, 2013

The Department of Health and Human Services (HHS) revealed in court filings yesterday that it expects to issue guidance regarding...

USDA

Judge Denies Attempt to Stop New COOL Rule

September 11, 2013

Opponents of USDA’s new mandatory Country-of-Origin-Labeling (mCOOL) rule received a setback this morning. A federal judge denied the mCOOL opponents...

Health Care

The FTC and Keeping Privacy Promises

September 9, 2013

In 2012, identity theft was the number one complaint reported to the Consumer Sentinel Network. Protection of private consumer information...

FDA

FDA Proposed Reg will be “Game Changer” for Auditing and Certification Organizations

September 6, 2013

Get ready, set, go! After years of delay, FDA is now on a fast-track to finalize its proposed regulation on...

USDA

Canada, Mexico Think U.S. Labeling Requirements are un-COOL

August 28, 2013

The United States has irked its neighbors with a meat labeling mandate that may have the effect of discriminating against...

FDA

PEW Report’s Mischaracterization of GRAS Process Leads to Questionable Conclusions

August 27, 2013

By Mark L. Itzkoff As someone who has worked with numerous food companies on food additive and GRAS issues for...

FDA

“Gluten-Free” Now Has an Official FDA Definition

August 9, 2013

FDA has published a final rule defining the term “gluten-free” for voluntary use in food labeling. Food labels will have...

FDA

FDA Tells Food Importers How It Wants Them To Verify the Safety of the Foods They Import

August 6, 2013

FDA has published two proposed rules to implement to provisions of the Food Safety Modernization Act (FSMA) related to the...

FDA

Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong?

August 1, 2013

On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act...

Miscellaneous

John Block Reports: How Lucky We Are

August 1, 2013

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports....

News & Insights

My Mobile Medical Application Will be Regulated by FDA…What Do I Do Now?

Ken Ackerman’s Latest History: Abraham Lincoln’s Spoiled Son

Citizen Suit Goes Down The Drain in Farm Tile Case

Bienvenue Aux Etats-Unis!

Universities Salute World Food Prize Commitment to Sound Science & Biotechnology

Building the Relationship

Is Livestock Causing Climate Change?

HHS Guidance Expands Scope of Refill Reminders and Reasonable Costs

Major Coalition, including Academia, Commends World Food Prize for Supporting Biotechnology

The Phone Call that Comes Too Late

It Is “That” Time of Year

Livestock & Meat Groups Want COOL Relief Pending WTO Review

FDA’s GRAS Review Process for Foods May Be Tested by Litigious Public Interest Group

MDR Reporting of Foreign Adverse Events — What is Your Obligation?

HITECH First Amendment Challenge Delayed – HHS Promises Guidance and Agrees to Limited Enforcement Delay

Judge Denies Attempt to Stop New COOL Rule

The FTC and Keeping Privacy Promises

FDA Proposed Reg will be “Game Changer” for Auditing and Certification Organizations

Canada, Mexico Think U.S. Labeling Requirements are un-COOL

PEW Report’s Mischaracterization of GRAS Process Leads to Questionable Conclusions

“Gluten-Free” Now Has an Official FDA Definition

FDA Tells Food Importers How It Wants Them To Verify the Safety of the Foods They Import

Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong?

John Block Reports: How Lucky We Are

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