News & Analysis as of

New Guidance Life Sciences Biologics

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

Stikeman Elliott LLP on

On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

Nelson Mullins Riley & Scarborough LLP

FDA Finalizes Informed Consent Guidance for Drug and Medical Device Clinical Investigations

On August 15, the U.S. Food and Drug Administration (FDA or the Agency) published the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final...more

Hogan Lovells

FDA offers new guidance on charging for investigational drugs

Hogan Lovells on

On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which responds to FAQs about FDA’s policies for charging...more

Morgan Lewis - As Prescribed

FDA Provides Much-Needed Guidance on Master Protocols for COVID-19 Drugs

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. ...more

Mintz - Trademark & Copyright Viewpoints

FDA Issues New Guidance on Drug Naming

Last week, the Food and Drug Administration (“FDA”) issued a pair of Guidance for Industry documents outlining best practices for developing proprietary names (i.e. brand names) for prescription and nonprescription human drug...more

Smart & Biggar

RxIP Update - 2016 Year in Review

Smart & Biggar on

The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more

7 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide