News & Analysis as of

Pharmaceutical Industry › Foreign Manufacturers

Epstein Becker & Green

Key Considerations for Reshoring U.S. Drug Manufacturing

Epstein Becker & Green on

This Diagnosing Health Care episode dives into the key business operations and legal considerations for reshoring active pharmaceutical ingredient (or “API”) and finished drug product manufacturing to the United States. The...more

Bergeson & Campbell, P.C.

Senate Finance Committee Holds Hearing on FDA’s Foreign Drug Manufacturing Inspection Process

Bergeson & Campbell, P.C. on

On June 2, 2020, the Senate Committee on Finance hosted a full Committee hearing entitled “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.” Witnesses represented the U.S. Food and...more

Hogan Lovells

Five key takeaways from the Senate hearing on FDA oversight of foreign drug manufacturing

Hogan Lovells on

The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system. ...more

BakerHostetler

FDA Current Good Manufacturing Practice Inspections During the COVID-19 Pandemic

BakerHostetler on

In an unprecedented time amid the global COVID-19 pandemic, an increasing number of pharmaceutical manufacturers and developers of active pharmaceutical ingredients are involved in the potentially life-saving development of...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Warning Letter for Refusal to Permit Inspection: Important Takeaways for Startups and Drug and Device Manufacturers

Wilson Sonsini Goodrich & Rosati on

Introduction: CGMPs and FDA Inspections - Current Good Manufacturing Practices (CGMPs) are mandated by regulations enforced by the U.S. Food and Drug Administration (FDA), and must be implemented and followed by...more

Wilson Sonsini Goodrich & Rosati

Administration Again Attempts to Lower Drug Prices

Wilson Sonsini Goodrich & Rosati on

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

Mintz - Health Care Viewpoints

In Policy Reversal, HHS and FDA Propose Plan to Import Foreign Drugs

Mintz - Health Care Viewpoints on

On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan, to allow certain entities to import...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues - July 2019

Wilson Sonsini Goodrich & Rosati on

Legislation - Biologics: Senate Health Committee Passes Bipartisan Legislation to Lower Health Care Costs - During the last week of June, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved...more

Patrick Malone & Associates P.C. | DC Injury...

Generic drugs ensnared in price-fixing and shoddy manufacturing claims

Patrick Malone & Associates P.C. | DC Injury... on

With Big Pharma pressing the limits in promoting and pricing prescription medications, patients and their advocates long have hoped that generic drugs might be difference-makers on costs and practices. Those positive wishes,...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Holland & Knight LLP

Shortage of Relief: Recent Disasters Highlight Multifaceted Drug Shortage Problem

Holland & Knight LLP on

• Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. • The island is home to multiple drug manufacturing facilities that are directly...more

Foley Hoag LLP

Product Liability Update - July 2015

Foley Hoag LLP on

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

Arnall Golden Gregory LLP

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

Arnall Golden Gregory LLP on

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

Cadwalader, Wickersham & Taft LLP

New York Court Affirms Jury Verdict Against Chinese Manufacturers Of Vitamin C, Awards Attorneys' Fees To Plaintiffs

Cadwalader, Wickersham & Taft LLP on

In a recently released decision, a federal court in New York has declined to overturn a jury’s $153.3 million verdict against vitamin C manufacturer Hebei Welcome Pharmaceutical and its parent, North China Pharmaceutical...more

14 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:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide