News & Analysis as of

Draft Guidance

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The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017.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AAM/Biosimilars Council Comments on FDA Draft Guidance on Interchangeability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for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, released comments today on FDA’s Draft Guidance on Considerations in Demonstrating Interchangeability With a Reference Product...more

EPA Will Publish Draft Guidance for Reporting Nanoscale Materials for Comment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to publish a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on...more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On November 23, 2016, the European Central Bank (ECB) published its draft guidance on leveraged transactions in order to establish guidelines on how to measure and monitor the exposure to leveraged lending for significant...more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

[Webinar] Biologics and Biosimilars: Development with an Eye Towards FDA Approval - February 17th, 10:00am PST/1:00pm EST

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...more

FDA Issues Draft Guidance on Demonstrating Interchangeability Under the BPCIA

by McCarter & English, LLP on

On January 17, 2017, the Food and Drug Administration (FDA) issued its long-awaited draft guidance on licensure as an interchangeable biological product approved under the Biologics Price Competition and Innovation Act of...more

FDA Issues Draft Guidance on Payor Communications

by McDermott Will & Emery on

Shortly after the recently enacted, bipartisan 21st Century Cures Act, which revised and expanded the extent to which specific health care economic information (HCEI) may be disseminated to certain stakeholders, and comes...more

FDA Says Sharing Medical Product Information is Caring, to an Extent

FDA recently issued a draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers”, which is intended to bring clarity to a specific provision in...more

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications

by Ropes & Gray LLP on

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

by Pepper Hamilton LLP on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

FDA Issues Draft Guidance on Biosimilar Interchangeability

by Ropes & Gray LLP on

On January 17, 2017, the Food and Drug Administration (FDA) issued draft guidance on “Considerations in Demonstrating Interchangeability With a Reference Product.” The draft guidance sheds light on the agency’s expectations...more

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