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Blog Post

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

09 August 2018

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from...

Blog Post

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

22 November 2017

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited...

Hogan Lovells Publications

Just in time: FDA finalizes guidance on assessment of abuse potential of drugs Focus On Regulation

25 January 2017

On 17 January 2017, just in time to evade the president's Regulatory Freeze Memorandum, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled "Assess...

Blog Post

Don’t Blink: 9th Circuit Issues Pivotal Decision on Enforcement of CSA Against Cannabis-ness

07 September 2016

As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule I.  As marijuana remains a Schedule I...

Blog Post

DEA Keeps Marijuana in Schedule I While Expanding Access for Research and Clarifying Rules on Hemp

12 August 2016

Yesterday, the U.S. Drug Enforcement Administration (DEA) took a number of actions regarding the federal control of marijuana, including denying a citizen petition to transfer the substance ...

Blog Post

FDA Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings

16 March 2016

FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for...

Blog Post

Pacira settlement could have ripple effects on a range of FDA issues far beyond promotional claims

07 January 2016

We continue to examine the Pacira case documents and give this settlement in-depth thought across all areas of our FDA regulatory practice. As we hinted in our December 17th post, we...

Blog Post

FDA Publishes Draft Guidances and Memorandum of Understanding on Drug Compounding and Repackaging

23 February 2015

On February 13, 2015, FDA issued four draft guidance documents and a draft memorandum of understanding (MOU) regarding the compounding of drug and biological products and the regulation of...

Blog Post

FDA revises forms for submission of patent information to the Orange Book: Federal Circuit decision in Novartis AG v. Lee alters patent term adjustment

27 February 2014

Two recent developments will affect the listing of patent information with pharmaceutical products approved by the U.S. Food and Drug Administration (FDA). First, the FDA has revised the...

Blog Post

FDA Calls for Nominations of Difficult to Compound Drugs

16 December 2013

The U.S. Food and Drug Administration (FDA) is required by statute to maintain a list of drug products that cannot be manufactured by pharmaceutical compounding because they are...

Blog Post

The First Drug with a Breakthrough Therapy Designation Receives FDA Approval

05 November 2013

On November 1, 2013, the Food and Drug administration (FDA) approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic...

Blog Post

Europe approves its first mAb biosimilar & FDA is handling 17 biosimilar INDs

07 October 2013

Not surprising after the European Medicines Agency (EMA) positive opinion for two biosimilars to Remicade (infliximab) in June, the first of these was authorized in September. ...

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