News & Analysis as of

Obama Administration Food and Drug Administration (FDA)

Goodwin

The Ten-Year Anniversary of the Enactment of the BPCIA

Goodwin on

Today, March 23, 2020, marks ten years since President Barack Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law as part of the Affordable Care Act. The BPCIA - whose legislation certain members...more

Searcy Denney Scarola Barnhart & Shipley

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Akin Gump Strauss Hauer & Feld LLP

What’s New in Washington: 10 Things You Need to Know

As the Trump presidency completes its first 10 weeks, the administration is celebrating big wins on the regulatory reform front while nursing some wounds from a major defeat on efforts to repeal and replace the Affordable...more

Morgan Lewis

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

Morgan Lewis on

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

King & Spalding

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

King & Spalding on

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

Bergeson & Campbell, P.C.

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and...more

Baker Donelson

Washington, D.C. Update – December 2016

Baker Donelson on

With the last-minute passage of a Continuing Resolution (CR) to stave off a government shutdown, the 114th Congress has come to an end. When Congress returns in January, it will be faced with a number of immediate challenges,...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

Ballard Spahr LLP on

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Announces 2016 Patents for Humanity Winners

On Thursday, the U.S. Patent and Trademark Office announced the latest winners of the Patents for Humanity program. The Patents for Humanity program, which was launched by the Office in February 2012 as part of an Obama...more

Mintz - Consumer Product Safety Viewpoints

Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

After launching with an ambitious agenda fourteen months ago, last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks. The Working Group has proposed an Update to...more

Foley & Lardner LLP

Capitalizing on Collaboration – The President’s Precision Medicine Initiative

Foley & Lardner LLP on

Last week President Obama marked the one year anniversary of his Precision Medicine Initiative (“PMI”) by holding a web-accessible panel discussion where he and interested stakeholders discussed his PMI initiative, its...more

Faegre Drinker Biddle & Reath LLP

Obama Administration Lays Out 2016 Regulatory Plans for Food and Agriculture

President Obama’s administration recently released its Regulatory Plan, which lays out department-specific regulatory priorities. Of interest to the food and agriculture industry are the agendas from the U.S. Department of...more

Mintz - Consumer Product Safety Viewpoints

FDA to Host First Public Meeting on Biotech Regulation Overhaul

On October 15, 2015, the Food and Drug Administration (FDA) posted notice of a public meeting to be held on Friday October 30th, in order to clarify the current roles and responsibilities described in the Coordinated...more

Mintz - ML Strategies

Food Labeling, Food Safety & Nutrition - July 2015

Mintz - ML Strategies on

The Obama Administration’s robust use of executive authority on issues related to food labeling, food safety, and nutrition continue to position these issues as a priority for the remainder of the President’s term in office....more

Mintz - Consumer Product Safety Viewpoints

GMOs in the Hotseat: White House to Overhaul Regulatory Framework on Biotechnology

Last week, the White House waded into the GMO regulatory fray with the Office of Science and Technology Policy’s (OSTP) announcement of a major overhaul of GMO regulation. In a statement released July 2, OSTP noted that...more

Bergeson & Campbell, P.C.

Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology

With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the...more

Mintz

Washington Outlook for 2015

Mintz on

In This Issue: - Introduction - Agriculture, Food Safety, and Nutrition - Appropriations, Budget, and Debt Ceiling - Defense and National Security - Education - Energy and Environment - Financial...more

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