News & Analysis as of

Regulatory Requirements Prescription Drugs Government Agencies

McDermott Will & Emery

A need for speed: FDA piloting voucher program to expedite drug review

McDermott Will & Emery on

On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more

Hogan Lovells

Investigation highlights risks of collaboration between pharmaceutical manufacturers and telehealth providers

Hogan Lovells on

Four U.S. senators reported their findings of a nine-month investigation into direct-to-consumer telehealth platforms used by pharmaceutical manufacturers, highlighting risks and reinforcing the need for industry to carefully...more

Stikeman Elliott LLP

Canada’s Drug Agency Launches Public Consultation on Proposed List of Essential Prescription Drugs and Related Products

Stikeman Elliott LLP on

On June 19, 2025, Canada’s Drug Agency (“CDA”) opened a public consultation to gather input on a proposed list of essential prescription drugs and related products. This initiative is part of the agency’s responsibilities...more

Smart & Biggar

CDA opens consultation on proposed list of drugs to inform development of national formulary

Smart & Biggar on

On June 19, 2025, Canada’s Drug Agency (CDA) opened a public consultation on a proposed process for preparing a list of essential prescription drugs and related products. As required by the Pharmacare Act, the CDA must...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Sheppard Mullin Richter & Hampton LLP

HRSA Announces New Requirements for FQHCs to Provide Insulin and Epinephrine at or below 340B Price

On June 24, HRSA announced that it had issued new grant award terms to its HRSA-funded health centers to provide insulin and injectable epinephrine at or below the 340B price paid by the health center for the drugs. HRSA...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Policy Shifts

BakerHostetler on

Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more

Knobbe Martens

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

Knobbe Martens on

The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more

Foley & Lardner LLP

GLP-1 Compounded Medications Targeted by Connecticut Attorney General

Foley & Lardner LLP on

On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more

Goodwin

State Drug Transparency Laws - 2025 Update

Goodwin on

We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more

Dinsmore & Shohl LLP

Mixing Medicine and Risk: Ohio’s Joint Regulatory Statement Targets Retail IV Therapy Clinics

Dinsmore & Shohl LLP on

On May 15, 2025, the State Medical Board of Ohio, the Ohio Board of Pharmacy and the Ohio Board of Nursing (collectively, the “Boards”) jointly issued a significant regulatory statement (the “Statement”) clarifying the legal...more

A&O Shearman

China advances pharmaceutical data protection regime with new Draft Measures

A&O Shearman on

On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Measures for the Protection of Drug Trial Data (the “Draft Measures”), along with its accompanying implementation guidelines, the...more

Akin Gump Strauss Hauer & Feld LLP

The Trump Administration Seeks to Spur Domestic Drug Manufacturing with Regulatory Relief EO

On May 5, President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines,” with the stated purpose of eliminating “regulatory barriers to the domestic production...more

Hogan Lovells

Reshoring EO aims to streamline permitting, approval, and oversight of US drug manufacturing

Hogan Lovells on

On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Mass Layoffs at FDA Could Have the Greatest Impact on Products in Development - The Trump Administration’s First 100 Days

Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more

Quarles & Brady LLP

Alabama Bill Rewriting Pharmacy Practice Act Clears Senate Hurdle

Quarles & Brady LLP on

As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more

Hogan Lovells

FDA Reduction-In-Force expected to impact drug & biologic review and regulation, other operations

Hogan Lovells on

Last week, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced an impending reduction in force (RIF) of approximately 10,000 positions, including about 3,500 Food and Drug Administration (FDA)...more

A&O Shearman

A new approach to regulation by the MHRA and NICE

A&O Shearman on

On March 17, 2025, the government published a policy paper with an Action Plan for regulation and regulators, outlining how it intends to reform the UK's regulatory system to support growth and innovation. The Action Plan...more

McDermott Will & Emery

This Week in 340B: March 11 – 17, 2025

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Smart & Biggar

New PMPRB Draft Guidelines outline administrative process for excessive price hearing recommendations

Smart & Biggar on

As we previously reported, on December 19, 2024, the Patented Medicine Prices Review Board (PMPRB) released its Draft Guidelines for PMPRB Staff regarding Administrative Process for Excessive Price Hearing Recommendation...more

Health Care Compliance Association (HCCA)

[Virtual Event] Louisville Regional Healthcare Compliance Conference - October 29th, 8:25 am - 4:30 pm EDT

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Philadelphia Regional Conference - May 29th, 8:30 am - 4:30 pm EDT

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

22 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