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Life Sciences The United States Food and Drug Administration

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

Outlook 2017 Teleconference: Revisiting the Trump Administration’s Impact on Life Sciences and Health Care—the First 100 Days

by Ropes & Gray LLP on

On Tuesday, May 2, Ropes & Gray hosted a teleconference, “Outlook 2017 Teleconference: Revisiting the Trump Administration’s Impact on Life Sciences and Health Care – the First 100 Days,” on the potential regulatory and...more

How Washington Can Help Biotechs

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

Right-to-Try or Right to Ask?

by Arnall Golden Gregory LLP on

Recently, the American Society of Clinical Oncology (ASCO), a prominent medical organization, announced that it does not support so called “right-to-try” laws. Right-to-try legislation, which has now gained support in 33...more

Life Sciences Quarterly – Preparing for and Managing a Stock Drop

by Ropes & Gray LLP on

A sharp drop in a company’s stock price frequently results in the filing of one or more securities class actions. 2016 saw the highest number of securities class actions since 2000, with more than 1 in 20 publicly traded...more

[Webinar] Investment Decisions for Investors and Entrepreneurs Considering 505(b)(2) Drug Applications: How to Make Sure Your...

by Robins Kaplan LLP on

Wednesday, April 19, 2017, 1:00 P.M. CST -- Are you an investor or entrepreneur considering 505(b)(2) drug applications? Join Jake Holdreith, Robins Kaplan, and Ken Phelps, Camargo Pharmaceutical Services for a complimentary...more

Boom Predicted in Biodegradable Stent Market

Stents, which are typically inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, have traditionally been made from metal mesh and remained in the body permanently (or until later...more

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

by Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

Trump's Proposed 2018 Budget Will Double FDA User Fees

by Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

by Foley & Lardner LLP on

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

February 2017: Life Sciences Litigation Update

Recently Amended FDA Rules Can Affect Settlements in Pharmaceutical Litigations. After more than thirteen years of bureaucratic analysis and rulemaking, the U.S. Food and Drug Administration recently implemented its new rules...more

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

by 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

Supreme Court Grants Certiorari in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

by King & Spalding on

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act

On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.” The...more

New Approach for Biologic and Biosimilar Names

by Morgan Lewis on

FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products. This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more

Biosimilars: Supreme Court Grants Certiorari in Amgen v. Sandoz

On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the...more

FDA Issues Final Guidance on Postmarket Cybersecurity

by Morgan Lewis on

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

What the FDA has in store for the food industry in 2017

by Thompson Coburn LLP on

As Life Sciences Decoded looks forward in 2017, it is clear that FDA-regulated industries have a great deal of change confronting them. Last year, 2016, was a landmark year for the FDA and food regulations, as the agency...more

When Time is Money

by Robins Kaplan LLP on

As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year...more

Is the FSMA a plaintiff’s lawyer’s dream and the food industry’s nightmare?

by Thompson Coburn LLP on

The Food Safety Modernization Act (FSMA) became law in 2011, signaling a sea change in U.S. food safety regulation and making prevention the cornerstone of safety measures. To achieve its lofty goals, while providing time for...more

FDA Issues Final Guidance on “Emerging Signals”

by Morgan Lewis on

Guidance addresses industry concerns about premature public notifications. On December 14, 2015, the FDA issued a final guidance titled “Public Notification of Emerging Postmarket Medical Device Signals” (Final...more

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