News & Analysis as of

Manufacturing Facilities Biologics

Latham & Watkins LLP

FDA Omnibus Reform Act: Examining the Policy Changes

Latham & Watkins LLP on

The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more

Goodwin

Expanding Operations in Biologics

Goodwin on

Catalent and Abzena both recently announced substantial investments into new biologics facilities. Catalent is spending up to $160 million to build a new manufacturing facility near Oxford, UK....more

Goodwin

Navigating the New Normal: Biomanufacturing Goes Local

Goodwin on

The pandemic has spared no industry. As fast-food chains have sought to drive business through chicken sandwich wars, Burger King’s release of its chicken sandwich was delayed in Michigan due to a shortage of pickle jars....more

Morgan Lewis - As Prescribed

Zooming in on Inspections: FDA Issues Guidance on Remote Interactive Evaluations and Roadmap on Inspectional Oversight

Over the past year and as a result of the COVID-19 pandemic, FDA relied on alternative inspectional tools and approaches, including remote interactive evaluations and record requests, as well as a prioritization scheme, to...more

Hogan Lovells

FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic

Hogan Lovells on

On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public...more

Mintz - Health Care Viewpoints

FDA’s Biologics Inspections in the (Negative) Limelight: Will Congress or Executive Leadership Take Action?

In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more

6 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