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Confidential Information Food and Drug Administration (FDA)

Ropes & Gray LLP

Protecting Trade Secrets in FDA Submissions from FOIA Disclosure in the Wake of FDA Layoffs

Ropes & Gray LLP on

In the wake of recent mass layoffs at the U.S. Food and Drug Administration (“FDA”), the FDA is likely to have fewer resources to manage its regulatory responsibilities. One area that may be significantly impacted by such...more

Foley & Lardner LLP

AI in Drug Discovery: 2025 Outlook

Foley & Lardner LLP on

Looking forward to the 2025 prediction season, a survey of the emerging AI-powered drug discovery landscape has been making the rounds—and with good reason. The survey, summarized by Stanford’s Chris Bradbury, is likely the...more

Proskauer - Minding Your Business

Court Finds Access to Botox Trade Secrets and Similarity of Competitor Product Supported Inference of Trade Secrets...

Proving access to and use of trade secrets are core elements in a trade secrets misappropriation case. Recent rulings in a trade secrets action filed by Allergan against its competitor Revance Therapeutics (“Revance”)...more

Epstein Becker & Green

What Do Cancelling Student Loan Debt and Banning Noncompetes Have in Common? The Supreme Court’s Recent Student Loan Decision May...

As we wrote almost exactly a year ago – months before the Federal Trade Commission (FTC) issued its proposed noncompete rule – the Supreme Court’s decision in West Virginia v. EPA made it clear that the FTC does not have the...more

McDermott Will & Emery

And the Band Played On: Reviewing Rule 54(b) Partial Summary Judgment Based on Who Did What to Whom and When

McDermott Will & Emery on

In a case where the cast of characters on both sides of the v. evolved during the lead-up to the litigation as the litigants negotiated third-party deals and formed new entities, the US Court of Appeals for the First Circuit...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Volume 3, Issue 6

Massachusetts-Based Background Check Company Creative Services Faces Multiple Lawsuits Over Data Breach - "'CSI determined that certain files dating from November 2018 to November 2021 may have been copied from their...more

Jackson Lewis P.C.

CDC Expands Guidance On Workplace SARS-CoV-2 Testing To Require Informed Consent

Jackson Lewis P.C. on

As employers continue to grapple with a safe return to the workplace, on January 21, the U.S. Center for Disease Control and Prevention (CDC) issued new guidance for businesses and employers on SARS-CoV-2 testing of...more

Clark Hill PLC

The EEOC Updates Employer Guidance to Address COVID-19 Vaccination

Clark Hill PLC on

The Equal Employment Opportunity Commission (EEOC) has updated its technical assistance questions and answers, What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws, to address COVID...more

Hogan Lovells

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Hogan Lovells on

Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more

Foley & Lardner LLP

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

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

Foley & Lardner LLP

Will You, Won't You Join The Biosimilar Patent Dance?

Foley & Lardner LLP on

In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the...more

Cadwalader, Wickersham & Taft LLP

2016 Year In Review: Securities Litigation And Regulation

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

Arnall Golden Gregory LLP

Der Markteintritt für deutsche IT Firmen aus dem Bereich des Gesundheitswesens

With expenditures of over $ 3 trillion of market in the field of health care in the United States is huge. Incentives of the Federal Government for the introduction of electronic medical records resulted increasingly in the...more

McGuireWoods LLP

DIA 2015 Provides Panels on All Types of FDA-Regulated Products with Many Opportunities for Insight and Interaction – Part Two of...

McGuireWoods LLP on

On the third day, the Center for Biologics Evaluation and Research (CBER) conducted its own Town Hall. CBER Director, Karen Midthun, explained how CBER works proactively to help develop new biological therapies. For example,...more

Bergeson & Campbell, P.C.

EPA and FDA Sign Memorandum of Understanding to Share Data

The U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have executed a Memorandum of Understanding (MOU) on Information Sharing regarding the sharing of data and other confidential...more

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