News & Analysis as of

Life Sciences Labeling Prescription Drugs

Sheppard Mullin Richter & Hampton LLP

FDA’s Second Untitled Letter of the Year – An Apparently Tough Choice Between Raising Awareness and Public Safety for Anaphylaxis...

On July 17, 2024—but just recently posted to the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) website—FDA issued its second untitled letter (letter) of the year to Kaleo, Inc....more

American Conference Institute (ACI)

[Event] 15th Summit on Biosimilars & Innovator Biologics - June 20th - 21st, New York, NY

Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

American Conference Institute (ACI)

[Webinar] 40th FDA Boot Camp - March 22nd - 23rd, 8:15 am - 1:30 pm EST

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more

Hogan Lovells

Brazil requires drug makers to add QR codes in package inserts and implement traceability systems

Hogan Lovells on

A new law was enacted in Brazil on May 12, 2022 (Law No. 14,338/2022) requiring that medicine package inserts will have to be provided in digital format, in addition to the existing written format. The law will require that a...more

Fish & Richardson

[Webinar] Life Sciences | 2020 Year in Review - January 27th, 1:30 pm - 2:30 pm ET

Fish & Richardson on

2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more

Goodwin

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

Goodwin on

On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect...more

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

King & Spalding

FDA and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

King & Spalding on

A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more

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