News & Analysis as of

Data Collection Pharmaceutical Industry

Venable LLP

Federal Agencies Increase Focus on Pricing Enforcement

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Last month, the Federal Trade Commission (FTC) and U.S. Department of Justice (DOJ) jointly hosted a public meeting of the interagency “Strike Force on Unfair and Illegal Business Practices.” The meeting was a continuation of...more

Womble Bond Dickinson

[Webinar] Innovation Interchange Summit: The Power Of Cross-Industry Insight - May 16th, 11:00 am - 4:00 pm ET

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Powerful ideas emerge when you look at something through a completely different lens. And when two parties come together to share those unique perspectives? That’s when the magic happens. Womble Bond Dickinson’s virtual...more

Alston & Bird

Health Care Week in Review: House Passes Minibus, HHS Releases Public Inquiry on Private Equity in Health Care

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

The BIOSECURE Act and Its Potential Implications

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Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more

Hogan Lovells

FDA updates 2016 guidance on the collection of race and ethnicity data

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The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document entitled, “Collection of Race and Ethnicity...more

Epstein Becker & Green

Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not...

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

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This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Cozen O'Connor

DOJ Signals Increased Emphasis on Data Analytics to Prosecute FCPA Global Corruption

Cozen O'Connor on

On November 29, 2023, Department of Justice (DOJ or Department) policymakers announced explicitly that they are, for the first time, leveraging data analytics to help proactively identify and prosecute crimes in foreign...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

King & Spalding

FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials

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The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more

Verrill

A Last-Minute Gift – Prescription Drug Reporting Grace Period and Good Faith Relief

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In a move akin to last-minute gift-giving, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) released FAQ 56 on December 23, 2022, which provides relief regarding the Prescription Drug...more

Ankura

How Pharmaceutical Companies Can Manage Data-Integrity Challenges

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Human health is a fundamental need of the society. The pharmaceutical industry has played a pivotal role in providing mankind with drugs for preventive and curative care. COVID-19 has further underscored the immense...more

King & Spalding

A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

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In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...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

Hanzo

Complying With the FDA’s Advertising Regulations: Why You Need an Interactive Website Archive

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Pharmaceutical advertising is big business. In 2020, pharmaceutical companies spent more than $6.5 billion on advertising. The Food and Drug Administration (FDA) regulates advertisements of prescription drugs, but it...more

Goodwin

Biden Executive Order Calls for Heightened Antitrust Scrutiny

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On July 9, 2021, President Joe Biden announced a broad executive order (the “Order”) intended to boost what it characterizes as stagnant competition across the U.S. economy. The Order, among other things, encourages the...more

Robins Kaplan LLP

Financial Daily Dose 4.12.2021 | Top Story: Chinese Regulators Hit Alibaba With $2.8B Antitrust Fine

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Chinese antitrust officials hit Alibaba with a “record” $2.8 billion fine over the weekend—the “biggest move yet in the government’s campaign to tighten its supervision of Big Tech.” ...more

K&L Gates LLP

Brussels Regulatory Brief: March 2021

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ANTITRUST AND COMPETITION - The European Commission Opens a New Investigation in the Pharma Sector - On 4 March 2021, the European Commission (Commission) has opened a formal investigation into alleged misuses of patent...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 5

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In Washington: The White House Coronavirus Task Force is warning that there may be a new fast-spreading U.S.A. variant of the coronavirus. "This fall/winter surge has been at nearly twice the rate of rise of cases as the...more

Sheppard Mullin Richter & Hampton LLP

On Your Mark, Get Set, Go: Life Science Companies Face A Challenging Year For Compliance With New Open Payment Program Data...

The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid...more

Robins Kaplan LLP

Financial Daily Dose 8.12.2020 | Top Story: 9th Circuit Reversed Antitrust Ruling Against Qualcomm

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Big win for Qualcomm this week, with a 9th Circuit panel reversing an antitrust verdict against the company that “had threatened the chip maker’s business model.” The appellate court, in flipping the district court’s ruling,...more

McDermott Will & Emery

[Webinar] Around the Corner: Evolving Opportunities and Challenges for Real-World Evidence and Data-Powered Solutions - August...

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Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more

BCLP

Have pharmaceutical companies complied with the requirement that companies disclose their collection and sharing by “enumerated...

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Yes and no. While pharmaceutical companies within the Fortune 500 universally disclose their collection of personal information by the “enumerated categories” within the CCPA, only 30.77% disclosed what information they...more

Robins Kaplan LLP

Financial Daily Dose 4.3.2020 | Top Story: The U.S. Jobs Report Will Be Ugly . . . .

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The U.S. Jobs Report Will Be Ugly: The March jobs report will likely show the worst numbers in the “post-World War II era,” and “it is playing out in a matter of weeks,” not years. One study suggests the U.S. has lost 27.9...more

Morgan Lewis

Back to the Future but Still in Flux: Court Finds Law Requires ClinicalTrials.gov Posting of Ten Additional Years of Additional...

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The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more

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