News & Analysis as of

Risk Mitigation Clinical Trials

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

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The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Society of Corporate Compliance and Ethics...

[Event] Higher Education & Healthcare Research Compliance Conference - June 10th - 12th, New Orleans, LA

Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

American Conference Institute (ACI)

[Complimentary Webinar] Mitigating Sanctions and Export Control Risks for Life Sciences, Research Institutes and Universities -...

Global life sciences companies, research institutes, and universities face unique challenges when complying with U.S. and non-U.S. trade control laws, including complying with general and specific licenses authorizing...more

Health Care Compliance Association (HCCA)

[Virtual Event] Hawaii Regional Healthcare Compliance Conference - October 7th, 7:55 am - 4:00 pm HST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

Epstein Becker & Green

[Virtual Briefing] Bias in Artificial Intelligence: Legal Risks and Solutions - March 23rd, 1:00 pm - 4:00 pm ET

Epstein Becker & Green on

You've likely seen the headlines. Online recruiting tools that unfairly screen out women and minorities. Facial recognition tools used in law enforcement that misidentify specific demographic groups. Algorithms that place...more

BakerHostetler

Promoting the Progress of Science: How Clinical Stage Patent Strategies Can Bring New Pharmaceuticals to Market

BakerHostetler on

Pharmaceutical companies only need patents for compositions of matter and general methods of use, right? Wrong. Discoveries can happen well into Phase III and IV and pharmaceutical companies should seek patent protection for...more

Wilson Sonsini Goodrich & Rosati

CMS Makes CAR T-Cell Cancer Therapy Available to Medicare Beneficiaries Nationwide

Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more

Dechert LLP

Dechert Survey: Developments in U.S. Securities Fraud Class Actions Against Life Sciences Companies

Dechert LLP on

Life sciences companies were popular targets of class action securities lawsuits in 2018. In the most recent edition of our annual survey, Dechert litigators David H. Kistenbroker, Joni S. Jacobsen and Angela M. Liu examine...more

Hogan Lovells

EMA’s revised Guideline on first-in-human trials increases the level of protection of trial participants

Hogan Lovells on

The European Medicines Agency (EMA) has released a new Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. The Guideline was adopted by...more

Hogan Lovells

The MHRA issues new guidance concerning common issues in clinical trial applications

Hogan Lovells on

On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the Agency has encountered during the validation and review of...more

Searcy Denney Scarola Barnhart & Shipley

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

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