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McDermott Will & Emery

Lowest-risk Clinical Trials Will Benefit From a New Notification Scheme and a Shorter Period for Application Processing

McDermott Will & Emery on

On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more

Nelson Mullins Riley & Scarborough LLP

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

Hogan Lovells

The new Clinical Trials Regulation – what you need to know now - Episode 4: Protection of vulnerable groups.

Hogan Lovells on

With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode : Protection of vulnerable groups This part of the series is about the protection of the...more

Quarles & Brady LLP

Georgia Board of Pharmacy Continues to Review Licensure Requirements for Pharmacists

Quarles & Brady LLP on

At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing. The discussion was aimed at new verbiage that would require...more

Quarles & Brady LLP

Kentucky Board of Pharmacy Continues to Research and Review Proposed Non-Resident Pharmacy Permit Regulations

Quarles & Brady LLP on

At the March 30, 2022 Kentucky Board of Pharmacy meeting, the Regulation Committee reported on its March 15 meeting where it discussed the new proposed non-resident pharmacy permit regulation. The Committee requested...more

Knobbe Martens

FDA Proposes Changes to Medical Device Quality Regulations

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) published on February 23rd, 2022, a rule proposal to overhaul medical device quality control regulation. According to the FDA, the proposed rule change would “amend the device...more

Foley Hoag LLP

Next Up: Uniform Licensure Standards for Wholesalers and Third-Party Logistics Providers

Foley Hoag LLP on

Key Takeaways: ▪️ FDA has published a proposed rule proposing national licensing standards for prescription drug wholesale distributors and third-party logistics providers as well as standards for third-party accreditation...more

Latham & Watkins LLP

European Healthcare & Life Sciences Market Update - H1 2022

Latham & Watkins LLP on

Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more

Jones Day

FDA Proposes National Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

Jones Day on

The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more

Quarles & Brady LLP

Texas Board of Pharmacy Sends Central Fill Amendment Back for Redraft but Signals Approval

Quarles & Brady LLP on

On February 1, 2022, the Texas Board of Pharmacy voted to send proposed amendments to its Central Fill Rule under 22 Tex. Admin. Code § 291.125 back to staff for a redraft....more

Kramer Levin Naftalis & Frankel LLP

NAIC Considers PBM Regulation; Additional Requirements Possibly on Tap

Pharmacy benefit managers (PBMs) should consider the implications of a model law making its way through the National Association of Insurance Commissioners (NAIC) that would establish a licensure requirement and rules of...more

Hogan Lovells

UK post-Brexit regulation of medicines from 1 January 2021

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate in England, Wales and Scotland (together Great...more

Hogan Lovells

China’s drug regulator seeks comments on updated drug recalls regulation

Hogan Lovells on

On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) proposed an...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

Hogan Lovells

New medical device regulation in Spain opened for public consultation

Hogan Lovells on

Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....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

Mintz - Health Care Viewpoints

The Other Shoe Drops: FDA Withdraws 30-Year-Old Homeopathic Drug Enforcement Policy and Puts Industry on Notice of Further...

To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA)...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Hogan Lovells

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Hogan Lovells on

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist...more

Hogan Lovells

FDA Chief of Staff: OTC reform remains “top priority” for FDA

Hogan Lovells on

Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top...more

Hogan Lovells

FDA Doubles Down on MUsT Studies for Sunscreens and Issues Final Guidance on Absorption Studies that Will Likely Be Needed for...

Hogan Lovells on

On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC drug monographs, including...more

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

Hogan Lovells

New UK MHRA No Deal Guidance

Hogan Lovells on

With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more

Hogan Lovells

Brexit snapshot: Medicines

Hogan Lovells on

Do you have a centralised EU marketing authorisation holder, orphan designation holder, manufacturing activities including import, batch control or batch release sites, a Qualified Person for Pharmacovigilance (QPPV),...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

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Updated: Dec 28, 2021:

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Updates to This Policy

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