News & Analysis as of

Draft Guidance

Goodwin

FDA Withdraws Draft Guidance Regarding Statistical Approaches to Evaluate Analytical Similarity of Biosimilars

by Goodwin on

As we previously reported, in September 2017 FDA issued draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity that “describes the type[s] of information a sponsor of a proposed biosimilar product...more

Fish & Richardson

New Draft Guidance on FDA Meetings, But Nothing Further on Substantive Requirements for Biosimilars and Interchangeables

by Fish & Richardson on

On June 5, 2018, the FDA released new draft guidance for the biosimilar industry. The draft guidance provides recommendations regarding the timing, scope and conduct of formal meetings between the FDA and applicants relating...more

Ropes & Gray LLP

FDA Issues Draft Guidance Regarding Waiver of Single Shared System REMS Requirement

by Ropes & Gray LLP on

FDA Commissioner Scott Gottlieb has vowed to take steps to speed the review and approval of generic drugs as part of his overall priority to address concerns about drug prices. While FDA has very limited authority regarding...more

White & Case LLP

The Delta Report – Derivatives Newsletter: June 2018 - Variation margin requirements for physically settled FX forwards — EMIR...

by White & Case LLP on

On 24 November 2017, the European Supervisory Authorities ("ESAs") issued a statement on the variation margin requirements in respect of physically settled FX forwards under Commission Delegated Regulation (EU) 2016/2251 of 4...more

Goodwin

FDA Announces New Draft Guidance on Meetings Regarding the Development and Review of Biosimilar or Interchangeable Products

by Goodwin on

On June 4, 2018, FDA announced the availability of a new draft guidance on formal meetings with FDA concerning the development and review of biosimilar or interchangeable biological products. The draft guidance, titled...more

Goodwin

FDA Releases Two Draft Guidances on REMS

by Goodwin on

For certain drugs with serious risks, the FDA may require drug developers to submit a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biologic outweigh its risks. We have previously...more

Knobbe Martens

China Drug Administration Proposes Pharmaceutical Data Protection Guidelines

by Knobbe Martens on

On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more

Hogan Lovells

The EMA opens a draft guideline for handling and shipping of investigational medicinal products for human use for public...

by Hogan Lovells on

On 23 May 2018, the European Medicine Agency (EMA) launched a public consultation for a draft guideline concerning the responsibilities of trial sponsors for handling and shipping of investigational medicinal products for...more

Arnall Golden Gregory LLP

When It Rains, It Pours In the Land of Sunscreens

by Arnall Golden Gregory LLP on

As Memorial Day approaches, FDA has shed light on several important facets of sunscreen regulation this week, issuing two draft guidances and four Warning Letters. One guidance is sunscreen specific: Enforcement Policy -- OTC...more

Pillsbury Winthrop Shaw Pittman LLP

New Proposed DoD Cyber Guidance May Fuel Bid Protest Docket

Newly published draft DoD Guidance for Reviewing System Security Plans (SSP) and the “NIST SP 800-171 Security Requirements Not Yet Implemented” answer some questions but may also result in an increased protest docket due to...more

Hogan Lovells

Hunting unicorns: German and Austrian Competition Authorities publish draft Guidance Note on Transaction Value Thresholds

by Hogan Lovells on

Since 2017, new merger control thresholds have been in effect in Germany and Austria which do not depend on the revenues generated by the parties but, rather, on the value of the transaction....more

Hogan Lovells

China Drug Administration publishes a key Draft Guidance on data exclusivity

by 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

Stinson Leonard Street

FDA Digital Health Update: Multiple Function Devices

by Stinson Leonard Street on

On April 27, the Food and Drug Administration (FDA) released its promised draft guidance document, Multiple Function Device Products: Policy and Considerations, explaining how it will regulate multiple function devices that...more

Cozen O'Connor

FDA releases draft guidance on expansion of abbreviated 510(k) Program

by Cozen O'Connor on

On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that...more

Arnall Golden Gregory LLP

(Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) Program

by Arnall Golden Gregory LLP on

The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating...more

Holland & Knight LLP

FDA Issues Draft Guidance on Bulk Substances for Compounding by Outsourcing Facilities

by Holland & Knight LLP on

On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use in compounding by outsourcing...more

Dentons

CMA guidance on requests for internal documents in merger investigations

by Dentons on

Companies and their advisers need to be even more vigilant about the contents of internal documents concerning proposed deals, because the Competition and Markets Authority (CMA) is tightening its procedure for requiring...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Countdown to December 2020: Brexit Draft Agreement Provides Some Clues for Trademark Impact

BREXIT! A word that might have been unthinkable a mere two years ago now raises so many questions for today’s trademark professionals – but some of those key questions were recently answered, at least for now. ...more

Robinson+Cole Health Law Diagnosis

FDA’s New Draft Guidance on Bulk Drug Substances in Compounding

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more

Akin Gump Strauss Hauer & Feld LLP

EU Trade Update

• European Commission publishes survey on concept of “Specially Designed for Military Use,” and issues request for input for possible EU commercial policy measures targeting the United States • Netherlands introduces...more

Holland & Hart LLP

Corps of Engineers to Streamline Section 408 Permitting Process

by Holland & Hart LLP on

In February 2018, the U.S. Army Corps of Engineers (“Corps”) issued a draft Engineering Circular (“EC”) outlining proposed policies and procedures regarding how it will address third-party requests to alter civil works...more

Shearman & Sterling LLP

European Banking Authority Seeks Feedback on Draft Guidelines on Managing Non-Performing Exposures

by Shearman & Sterling LLP on

The European Banking Authority has commenced a consultation on draft Guidelines on the management of non-performing and forborne exposures. The Capital Requirements Directive requires in-scope banks and investment firms to...more

Pillsbury Winthrop Shaw Pittman LLP

EU Publishes Draft Guidelines for Future Relationship with Britain

The guidelines present a stark contrast to Prime Minister May’s vision of a “deep and special” partnership with the EU after Brexit. The President of the European Council has issued negotiating guidelines for the future...more

White and Williams LLP

FDA Releases Draft Guidances to Enhance Drug Supply Chain Security

by White and Williams LLP on

On March 1, 2018, the U.S. Food and Drug Administration (FDA) issued two new draft guidances which further the FDA’s implementation of the Drug Supply Chain Security Act (DSCSA). The DSCSA amended the Federal Food, Drug, and...more

Arnall Golden Gregory LLP

Urgent, Urgent, Urgent … Emergency: FDA Advises Companies to Issue Appropriate Product Recall Warnings

by Arnall Golden Gregory LLP on

Channeling the rock band Foreigner and its 1981 hit, “Urgent” (or the Beatles’ “Get Back” single), the Food and Drug Administration issued a draft guidance in January 2018, cautioning industry to properly warn the public...more

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JD Supra Privacy Policy

Updated: May 25, 2018:

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Information for EU and Swiss Residents

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Changes in Our Privacy Policy

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Contacting JD Supra

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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