Publications

Hogan Lovells Publications

China Drug Administration publishes a key Draft Guidance on data exclusivity for pharmaceuticals

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...

Hogan Lovells Publications

Much to metabolize: The 21st Century Cures Act introduces numerous changes to FDA’s drug regulatory framework to spur development of new treatments

The 21st Century Cures Act (Cures Act) has become law with measures designed to deliver new cures and treatments to patients.  Among these measures are a broad range of changes to the...

Hogan Lovells Publications

The New Hatch-Waxman Regulations: A First Look

On October 6, 2016, FDA published a final rule implementing portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) that govern ANDAs and...

Hogan Lovells Publications

The market for biosimilars is growing in spite of unanswered questions

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and...

Hogan Lovells Publications

New VA Policy Regarding TAA Non-Compliant Covered Drugs

The Department of Veterans Affairs (VA) recently announced a fundamental shift in policy that will now require manufacturers to list Veterans Health Care Act (VHCA) covered drugs (i.e.,...

Hogan Lovells Publications

International Product Liability Review - Issue 61

The International Product Liability Review provides quarterly updates and comment from around the world on legal developments in the field of product liability and product safety.

Hogan Lovells Publications

Bring Your Own Smartphone: FDA Requests Comments on the Use of Innovative Technologies to Conduct Clinical Trials

On October 29, 2015, FDA issued a notice requesting comments on the use of new technologies – such as smart phones, tablets, and wearable technology – to recruit for and conduct drug...

Hogan Lovells Publications

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

On February 13, 2015, the FDA issued four draft guidance documents and a draft memorandum of understanding (MOU) regarding the compounding of drug and biological products and the regulation ...

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