News & Analysis as of

Generic Drugs Regulatory Standards

K&L Gates LLP

An Overview of the US Food and Drug Administration's Legislative Goals (Part I)

K&L Gates LLP on

In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more

Jones Day

Tillis Urges FDA, USPTO to Investigate Potential False Narrative by Drug Critics

Jones Day on

On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more

Pullman & Comley - Connecticut Health Law

Post-Public Health Emergency – Connecticut Pharmacy Limitation Changes

Connecticut has recently notified pharmacies and prescribing providers that various quantity limits and refill criteria will revert back to pre-COVID 19 requirements come May 21, 2021. The reinstatement of pre-COVID 19...more

Hogan Lovells

China’s NMPA releases proposal for modified “Hatch Waxman” following patent law reform

Hogan Lovells on

On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed regulation on patent linkage, “Measures for the Implementation of the Early...more

Mintz - Health Care Viewpoints

Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020

Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more

Hogan Lovells

New drug marketing applications: how do EMA and FDA compare?

Hogan Lovells on

A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more

Hogan Lovells

The Court of Justice clarifies the EU customs rules applicable to customs valuation

Hogan Lovells on

The Court of Justice of the European Union (“Court”) just released its judgement in Case C-1/18 Oribalt Riga concerning the customs valuation methodologies applicable to generic medicines in the framework of consignment...more

Hogan Lovells

Updated UK “no deal” Brexit guidance on medicines, medical devices and clinical trials

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2018

Goodwin on

Here are our picks for the most significant U.S. regulatory developments related to biosimilars in 2018: 1. FDA Releases Biosimilars Action Plan - In July, FDA released the Biosimilar Action Plan (BAP), which outlines...more

Goodwin

Regulatory News Roundup

Goodwin on

Below are some recent regulatory developments in the biologics space. As we previously reported, USP has been considering a revision to the naming conventions for the titles of biologics product monographs. ...more

Hogan Lovells

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

Hogan Lovells on

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

Goodwin

FDA Announces New Draft REMS Guidance

Goodwin on

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all...more

McGuireWoods LLP

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part One of Two

McGuireWoods LLP on

On September 16-18, 2015 the International Generic Pharmaceutical Alliance (IGPA) held its 18th Annual Meeting in Toronto, Canada. IGPA is composed of members: the Canadian Generic Pharmaceutical Association (CGPA-Canada),...more

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