News & Analysis as of

Pharmaceutical Industry › Antimicrobials

Hogan Lovells

FDA warns animal drug companies over unapproved antimicrobials, identifying “public health concerns”

Hogan Lovells on

In December 2023, the U.S. Food and Drug Administration (FDA) issued nine Warning Letters for the manufacture and distribution of unapproved over-the-counter (OTC) antimicrobial animal drugs for use in aquarium fish and...more

A&O Shearman

European Union to introduce a transferable exclusivity voucher to incentivize the development of new antimicrobials

A&O Shearman on

The European Commission (EC) has just published its draft proposals to overhaul the European Union (EU) general pharmaceutical legislation. Tackling the problem of antimicrobial resistance was a key priority in the 2020...more

Fox Rothschild LLP

FDA Issues Guidance Recommending That Animal-Approved Over-The-Counter Medically Important Antimicrobial Drugs Are Required To Be...

Fox Rothschild LLP on

FDA recently published Guidance #263 titled, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to...more

Kilpatrick

Legislative Update: The PASTEUR ACT – Incentivizing Discovery and Development of Novel Antimicrobial Drugs

Kilpatrick on

With everything that was happening this past winter, it would have been easy to miss the introduction of S. 4760: The PASTEUR Act. On December 9, U.S. Representatives Mike Doyle (D-PA) and Drew Ferguson (R-GA) introduced the...more

Kilpatrick

Legislative Update: Incentivizing Discovery and Development Investment into Novel Antimicrobial Drugs

Kilpatrick on

According to the Centers for Disease Control and Prevention (CDC) 2019 report Antibiotic Resistance Threats in the United States (“CDC Report”), “more than 2.8 million antibiotic-resistant infections occur in the United...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter - December 2020: Antimicrobial Resistance (AMR) – A Personal Perspective

Dechert LLP on

“Our world faces a silent, slow-moving global threat that kills around 700,000 people each year due to the uncontrolled rise of superbugs resistant to antibiotics. These superbugs can affect anyone, of any age, in any...more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - December 2018 #4

BakerHostetler on

Food/Dietary Supplements - FDA Commissioner Announces Ongoing Services During the Partial Government Shutdown – The FDA released a statement that certain programs would continue to run during the shutdown. ...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

Bergeson & Campbell, P.C. on

EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

8 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