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Today's Popular Updates › Biologics › Clinical Trials

A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Ropes & Gray LLP

China Formalizes Regulatory Data Protection Mechanism

Ropes & Gray LLP on

Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more

Morgan Lewis

Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead

Morgan Lewis on

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be no exception to this rule, and with its arrival we examine FDA’s activities...more

Arnall Golden Gregory LLP

Life in the Fast Lane: FDA Issues New Draft Guidance for Accelerated Approval of Drugs and Biologics

Arnall Golden Gregory LLP on

In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, the Food and Drug Administration began offering pharmaceutical companies their own...more

Goodwin

FTC Comment on FDA Draft Guidance on Interchangeability

Goodwin on

We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

Hogan Lovells

Six strategies for clinical trial & marketing application success as FDA requires HCT/P BLAs

Hogan Lovells on

Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products (HCT/Ps) will be required to file a biologics license application (BLA) with...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Patterson Belknap Webb & Tyler LLP

The FDA Regulatory Landscape for Covid-19 Treatments and Vaccine (Updated #2)

Patterson Belknap Webb & Tyler LLP on

September 17, 2020 Update: The Trump administration is currently considering accelerating the approval of an experimental Covid-19 vaccine being developed by Oxford University and AstraZeneca. In line with FDA’s June 2020...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

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