News & Analysis as of

Draft Guidance

FDA Establishes Electronic Privacy, Security, and Reliability Criteria for Clinical Trial Records

by Jones Day on

In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more

UPDATE: New UK Offences of Failure to Prevent Facilitation of Tax Evasion – looming deadline

by Ropes & Gray LLP on

In May 2016, we published an Alert about UK proposals to introduce new strict liability corporate criminal offences aimed at preventing the facilitation of tax evasion. Andy Howard, Tax partner in the Ropes & Gray London...more

Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical...

by Hogan Lovells on

On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 — Questions and Answers." The draft guidance is...more

New York Issues Draft Guidance on New Contractor Salary Disclosure Requirement, Seeks Public Comment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

DOL Withdraws Obama-Era Administrator’s Interpretations on Independent Contractors and Joint Employment

Employers across the U.S. were troubled by the sub-regulatory guidance issued by the DOL in 2015 and 2016 on independent contractors and joint employment. Today, the DOL announced the withdrawal of that guidance...more

EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

by Hogan Lovells on

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (“Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation. The Draft Guideline updates the previous guideline on TMF that...more

Part III: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

This post, Part III, of a three-part series on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA....more

Part II: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

This post, Part II, of a three-part series (Part I) on FDA’s interchangeability draft guidance, highlights the key issues that were raised in the stakeholder comments provided to FDA. FDA received 52 comments in total from a...more

Belgian Financial Regulator's Tightening of Investor Protection Against Unfair Contract Terms

by Jones Day on

On 6 February 2017, Belgium's financial regulator (Belgian Financial Services and Markets Authority ("FSMA")) moved to fortify the protection of investors, publishing a position paper ("Position Paper") on the application of...more

TSCA Nanomaterial Reporting Rule: EPA Delays Effective Date and Releases Draft Guidance for Public Comment

by Beveridge & Diamond PC on

The U.S. Environmental Protection Agency (“EPA”) issued its Draft Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce ( “Draft Guidance”) on May 16, 2017. See 82 Fed. Reg. 22452 (May 16,...more

ECB Publishes Final Guidance on Leveraged Transactions— What This Means for Banks

by Shearman & Sterling LLP on

After a period of public consultation, the European Central Bank (the “ECB”) published its final Guidance on Leveraged Transactions (the “Guidance”) on 16 May 2017. Twenty-four organisations (comprising credit institutions...more

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

AAM/Biosimilars Council Comments on FDA Draft Guidance on Interchangeability

by Goodwin on

The Association for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, released comments today on FDA’s Draft Guidance on Considerations in Demonstrating Interchangeability With a Reference Product...more

EPA Will Publish Draft Guidance for Reporting Nanoscale Materials for Comment

by Bergeson & Campbell, P.C. on

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on...more

NIST Releases Draft Cybersecurity Guidance for Wireless Infusion Pumps

The National Institute of Standards and Technology (NIST) announced this week that it has issued draft cybersecurity guidance for hospitals to consider when using infusion pumps, particularly since infusion pumps are no...more

Lending Cap to be imposed by ECB – Will the new ECB guidance adversely affect leveraged transactions?

by Hogan Lovells on

On November 23, 2016, the European Central Bank (ECB) published its draft guidance on leveraged transactions in order to establish guidelines on how to measure and monitor the exposure to leveraged lending for significant...more

The Information Commissioner’s Guidance on Consent under the GDPR

by Ropes & Gray LLP on

The General Data Protection Regulation (the “GDPR”) came into force in May 2016 and makes numerous changes to European data protection laws. Among other things, the GDPR updates the rules on the use of consent by data...more

Draft EU Guidelines for Payment Service Providers on Preventing Terrorist Financing and Money Laundering in Electronic Fund...

by Shearman & Sterling LLP on

The Joint Committee of the European Supervisory Authorities has published a consultation on proposed guidelines on preventing terrorist financing and money laundering in electronic fund transfers under the EU Wire Transfer...more

China Issues Draft Measures to Restrict the Overseas Transmission of Personal Data

by Latham & Watkins LLP on

The Cyberspace Administration of China (CAC) issued Draft Measures for public comment on April 11 on Security Assessment for Cross-border Transmission of Personal Information and Critical Data (the Draft Measures). The Draft...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

Bond Issues

by White & Case LLP on

France’s draft Ordinance and Decree of 30 January 2017 for improving the development of French law-governed bond issues The capital markets’ share of corporate financing, and of the economy in general, is growing year on...more

UK Regulator Publishes Draft Guidance on Treatment of Politically Exposed Persons

by Shearman & Sterling LLP on

The Financial Conduct Authority has published draft Guidance on the treatment of politically exposed persons under the UK draft Money Laundering, Terrorist Financing and Transfer of Funds (Information on the Payer)...more

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

by Foley & Lardner LLP on

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

Finally! FDA Issues a Draft Guidance on Interchangeable Biosimilars

In mid-January, the US Food and Drug Administration (FDA) issued a much-anticipated draft guidance on interchangeable biosimilars titled "Considerations in Demonstrating Interchangeability With a Reference Product" (January...more

Decoding New FDA Nutrition And Supplement Facts Guidance

The U.S. Food and Drug Administration continues to fulfill its promise to provide food and dietary supplement companies with additional guidance on complying with the new final rules amending nutrition facts label...more

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Cybersecurity

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