News & Analysis as of

Data Collection Draft Guidance

Clark Hill PLC

[Webinar] A Cookieless Future and Promise of PETs: A Primer on Privacy Enhancing Technologies - March 7th, 10:00 am PT

Clark Hill PLC on

Regulators and plaintiffs’ attorneys are increasingly focused on privacy harms related to the collection and use of personal data. Could privacy enhancing technology (PETs) be a solution to these concerns?...more

Hogan Lovells

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

Hogan Lovells on

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continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document entitled, “Collection of Race and Ethnicity...more

Gardner Law

FDA Issues Draft Guidance on Real-World Evidence Use

Gardner Law on

In December 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of real-world evidence to support regulatory decision-making for medical devices. While the guidance is currently in draft form...more

Foley & Lardner LLP

Decentralized Clinical Trials: Sponsor Responsibilities

Foley & Lardner LLP on

In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more

King & Spalding

FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials

King & Spalding on

The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more

BakerHostetler

FDA Issues New Guidance for Collecting Postmarketing Data on Underrepresented Patient Populations

BakerHostetler on

In a notable step toward more equitable healthcare, the U.S. Food and Drug Administration (FDA) introduced new draft guidance on August 10, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical...more

Husch Blackwell LLP

CPRA Draft Regulations Issued

Husch Blackwell LLP on

Keypoint: The California Privacy Protection Agency issued a first set of draft regulations that contain a number of notable provisions but do not address all of the CPRA’s rulemaking topics....more

Foley Hoag LLP

FDA Issues Draft Guidance Recommending "Race and Ethnicity Diversity" Plans for Clinical Trial Sponsors

Foley Hoag LLP on

Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more

Hogan Lovells

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

Hogan Lovells on

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

Wilson Sonsini Goodrich & Rosati

EU Privacy Regulators Issue Draft Guidelines on Connected Vehicles and Mobility Applications

On February 7, 2020, the European Data Protection Board (EDPB) published draft guidelines on the processing of personal data in the context of connected vehicles and mobility related applications. If adopted in their current...more

Akin Gump Strauss Hauer & Feld LLP

AI Auditing Framework – Draft ICO Guidance Published for Consultation

On February 19, 2020, the Information Commissioner’s Office (ICO), the data protection regulator in the United Kingdom, launched a consultation on its draft guidance on the artificial intelligence (AI) auditing framework. ...more

Jones Day

Facing FIRRMA: CFIUS Review of the Biotechnology and Life Sciences Sector

Jones Day on

The Situation: The Committee on Foreign Investment in the United States ("CFIUS," or the "Committee") recently published draft regulations implementing the Foreign Investment Risk Review Modernization Act ("FIRRMA"), which...more

Robinson+Cole Data Privacy + Security Insider

CCPA Draft Regulations Expected in October

Bloomberg Law reported this week that California Attorney General Xavier Becerra expects to issue draft regulations for the California Consumer Privacy Act (CCPA) in October....more

Hogan Lovells

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare...

Hogan Lovells on

On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more

Hogan Lovells

China Drug Administration publishes a key Draft Guidance on data exclusivity

Hogan Lovells on

This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more

Skadden, Arps, Slate, Meagher & Flom LLP

New York Issues Draft Guidance on New Contractor Salary Disclosure Requirement, Seeks Public Comment

On June 1, 2017, the state of New York’s Department of Economic Development (the department) issued draft forms and guidance to capture employee salary information from New York state contractors and subcontractors pursuant...more

Bergeson & Campbell, P.C.

EU Issues Guidance to Clarify Transitional Measures for Data Requirements for Plant Protection Products and Active Substances

The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements...more

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