News & Analysis as of

Supply Shortages Prescription Drugs

Axinn, Veltrop & Harkrider LLP

Can an Enhanced India-U.S. Partnership Reduce Drug Supply Chain Issues?

In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred partnership between the U.S. and India can not only lower drug prices in the U.S. but can improve...more

McDermott+

Breaking Down Federal Policies to Address Drug Shortages

McDermott+ on

In the wake of persistent drug shortages that compromise patient care and safety, the Biden administration and Congress have proposed policies to strengthen the pharmaceutical supply chain. Using authorities under both...more

McDermott+

HHS Releases New Proposal to Address Drug Shortages

McDermott+ on

A few weeks ago, Regs & Eggs focused on nine health-related issues that were not included in the Fiscal Year (FY) 2025 President’s Budget. Another policy absent from the budget was the Administration’s plan to address drug...more

Foley Hoag LLP

Federal Regulators Examine the Role of Drug Supply Middlemen on Drug Shortages

Foley Hoag LLP on

The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) are soliciting public comments on the root causes of and potential solutions to drug shortages. The request for information (RFI)...more

Axinn, Veltrop & Harkrider LLP

Will India Replace China in the U.S. Drug Supply Chain?

In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more

Axinn, Veltrop & Harkrider LLP

Biden Administration Promotes Domestic Pharmaceutical Production to Reduce Drug Shortages

I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more

Axinn, Veltrop & Harkrider LLP

Thankful for Pharmaceuticals . . . Especially When There are Shortages

5 When our children were young, we started a tradition at Thanksgiving of going around the table and having each of us (around 20 with extended family) saying what we were thankful for. Of course, you hear a lot of being...more

Akin Gump Strauss Hauer & Feld LLP

10 Health Issues to Watch as Congress Returns from August Recess

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

Morgan Lewis - As Prescribed

The Current State of FDA’s Drug Shortage Playbook

As drug shortages are once again front-page crises news, demanding drastic action by FDA—currently with a particular focus on sterile, injectable platinum-based chemotherapy drugs—a refresher on the scope of FDA’s tools to...more

A&O Shearman

Drug shortages Belgian Royal Decree adopted which sets conditions for export authorisation

A&O Shearman on

The Royal Decree of 19 January 2023 (the Royal Decree) concerning the shortage of medicines (i) details the conditions under which a prior authorisation is required to export medicines aimed for the Belgian market to other EU...more

Smart & Biggar

New guidance documents and regulatory amendments regarding therapeutic product shortages

Smart & Biggar on

As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more

Smart & Biggar

Regulatory amendments provide permanent measures to address therapeutic product shortages

Smart & Biggar on

On September 1, 2021, Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the “Regulations”) were published in Part II of the Canada Gazette. These amendments are intended to provide...more

King & Spalding

Pharmaceuticals and Active Pharmaceutical Ingredients - Biden Administration Issues 100-Day Supply Chain Review Report

King & Spalding on

On June 8, 2021, four Executive Branch Departments issued reports mandated by President Biden’s February 24, 2021 Executive Order on America’s Supply Chains (the “America’s Supply Chains E.O.” or the “E.O.”). The E.O....more

Smart & Biggar

Health Canada – COVID-19 update highlights

Smart & Biggar on

UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Smart & Biggar

U.S. rule permitting import of drugs from Canada prompts Health Canada to release Interim Order prohibiting exports that may risk...

Smart & Biggar on

UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Smart & Biggar

Health Canada issues Interim Order respecting drug shortages related to COVID-19

Smart & Biggar on

UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Spilman Thomas & Battle, PLLC

The “Preventing Essential Medical Device Shortages Act of 2020”: COVID-19 Side Effect that Could Permanently Harm Medical Device...

The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the...more

White & Case LLP

Implications of the CARES Act for International Trade

White & Case LLP on

On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the purpose of which is to provide emergency assistance and health care responses for individuals,...more

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