Life Sciences The United States Food and Drug Administration

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Blog: Federal Court Gives Teeth to Operational Efforts Covenant in Sanofi/Genzyme Earn-Out Dispute

We keep a close eye on developing cases regarding earn-outs and contingent payment rights in light of the prevalent use of these arrangements in life sciences deals and their increasing use in non-life sciences deals. On...more

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist....more

FDA Convenes Two-Day Public Hearing on Human Cell and Tissue Product Regulatory Paradigm

As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell...more

FDA Regulatory and Compliance Monthly Recap — August 2016

FDA issues draft guidance on use of real-world data in medical device decision-making - The Food and Drug Administration’s draft guidance provides an overview of how the agency will determine the quality and reliability...more

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

Protecting Food Industry Whistleblowers: FDA, OSHA team up under FSMA

In 2011, when the Food Safety Modernization Act was passed, it sought to revamp food safety in the United States. Since then, the Food and Drug Administration (FDA) has been hard at work passing regulations to implement the...more

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

AGG Food and Drug Newsletter - June 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

FDA Regulatory and Compliance Monthly Recap – May 2016

FDA draft guidance provides recommendations on use of electronic health record data in clinical trials - The draft guidance provides recommendations on deciding whether and how to use EHRs as a source of data in clinical...more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

Celltrion Opposes Expedited Trial and Delayed Launch Date

On Monday, Celltrion filed a response to the letter Janssen submitted to the Court on April 12 requesting an expedited trial schedule. Celltrion maintains that Janssen improperly argues the merits of Janssen’s claim of...more

FDA Active on the Device Front for Q1 2016

Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more

Alert: Life Sciences Company Hit with $4 Million SEC Penalty

On March 29, the US Securities and Exchange Commission announced that AVEO Pharmaceuticals, Inc., a Massachusetts-based pharmaceutical company, agreed to pay a $4 million penalty to settle fraud charges that it failed to...more

AGG Food and Drug Newsletter - February 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Lessons from Latham & Watkins’ Representation of Pacira Pharmaceuticals In Ground-Breaking Settlement with FDA

FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn? On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

[Event] 2015 Business of Personalized Medicine Summit - Oct. 7, San Francisco, CA

Just as with patient treatments, one size does not fit all when it comes to companies involved in personalized medicine. Each is unique in its mission, culture, and capabilities, and so it should come as no surprise that each...more

Long-awaited overhaul of FDA food safety rules arrives – Part I: Introducing HARPC, changes to cGMP

Since the passage of the Food Safety Modernization Act in 2011, the FDA has promulgated proposed rules that overhaul the old Good Manufacturing Practice (cGMP) rule and create new Hazard Analysis and Risk-Based Preventative...more

Edwards Completes Acquisition of CardiAQ

According to PRNewswire, Edwards Lifesciences Corporation recently completed its acquisition of CardiAQ Valve Technologies, Inc, a developer of transcatheter mitral valve replacement systems, which follows from Edwards’...more

Agencies Release Proposed Overhaul of the Common Rule

On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the...more

Generating Life Sciences Brand Names: 5 Key Tips

In the challenging and complex world of life sciences product development, choosing a brand that survives the US Patent and Trademark Office and US Food and Drug Administration clearance processes is critical. Brand names in...more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

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