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Regulatory Oversight › Life Sciences › Proposed Rules

Sheppard Mullin Richter & Hampton LLP

What’s Going on with Human Cell and Tissue Products?

Sheppard Mullin Richter & Hampton LLP on

Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same....more

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

Bennett Jones LLP

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

Bennett Jones LLP on

Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more

Troutman Pepper Locke

FDA Proposes Submission Tracking Number Requirement for ENDS Imports

Troutman Pepper Locke on

In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

Bass, Berry & Sims PLC

The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

Bass, Berry & Sims PLC on

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more

Hogan Lovells

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

Hogan Lovells on

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket approval) devices to class II (subject...more

Hogan Lovells

FDA proposes streamlining combination product regulations

Hogan Lovells on

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more

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