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Life Sciences › Risk Assessment › Pharmaceutical Industry

Fenwick & West LLP

Balancing AI-Powered Drug Discovery’s Risk and Reward

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AI is shaving years off the drug-discovery process. But it’s not just leaving other research modalities in the dust—the law itself is struggling to keep up, especially when it comes to patenting AI-aided drug discovery....more

Lowenstein Sandler LLP

The BIOSECURE Act: Proposed New Legislation Could Affect U.S. Companies’ Plans to Contract With Chinese Biotechnology Companies

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The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more

Arnall Golden Gregory LLP

I’m Looking Through You/You Won’t See Me: FDA Issues Guidance Document Concerning Presentation of Certain Information in DTC...

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“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy...more

Butler Snow LLP

Cybersecurity: What Businesses Need to Know

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Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more

Alston & Bird

FDA Issues Notice on Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities and Requests...

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Our FDA Compliance & Enforcement Team highlights key takeaways from the Food and Drug Administration’s notice identifying scientific and regulatory considerations for nitrosamine drug substance-related impurities (NDSRIs) in...more

Quarles & Brady LLP

FDA May Require Opioids to be Dispensed with Mail-Back Envelopes and Related Patient Education

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The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more

Hogan Lovells

FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle - Patient experience data can...

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The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more

Hogan Lovells

EMA and HTA bodies jointly review a proposed EU framework for patient preference studies

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The European Medicines Agency (“EMA”) and the EU network of Health Technology Assessment (“HTA”) bodies are jointly reviewing a proposed framework for patient preference studies. The intention of the proposed framework is to...more

Skadden, Arps, Slate, Meagher & Flom LLP

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

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Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

McDermott Will & Emery

The EU Medical Device Regulation: What’s Next?

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The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

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On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

King & Spalding

General Counsels Decision Tree for Investigations of Life Sciences Companies

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Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more

Knobbe Martens

FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

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The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices....more

Hogan Lovells

FDA releases four final guidances on the 510(k) program; Special 510(k) guidance confirms new approach to eligibility and broader...

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On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program. ...more

Hogan Lovells

Final guidance provides additional clarity to the Humanitarian Device Exemption program

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On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program." ...more

Thomas Fox - Compliance Evangelist

Risk in Compliance Week: Part I – Forecasting

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This week I will feature a series on risk in compliance where I will be joined by Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment...more

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