Latest Posts › Pharmaceutical Industry

Share:

FDA Issues New Warning Regarding Compounded Ketamine

On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more

Key Contractual Considerations for Health AI and Hospital Collaborations

If artificial intelligence (AI) is the vehicle that will revolutionize health care, data is the fuel that will propel the revolution. Health AI startups have recognized an unprecedented opportunity to create a transformative...more

DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information

In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription...more

Get Real: Preventing Counterfeit Product with Blockchain

The counterfeit business is booming. In fact, counterfeit goods account for a whopping 3.3% of global trade and cost the U.S. economy approximately $600 billion a year. The Dangers of Counterfeit Products - Counterfeiting...more

Round Two - FDA Issues Emergency Use Authorization for Moderna’s COVID-19 Vaccine

What You Need to Know: On December 18, 2020, the Food and Drug Administration issued the second emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 18 years of age and older. Under...more

FDA Issues Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine

What You Need to Know: Late on December 11, 2020, the Food and Drug Administration issued the first emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 16 years of age and older....more

FDA Increases Scrutiny of COVID-19 Serology Tests: What Commercial Manufacturers Need to Know

On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more

DOJ Issues Guidelines for Enforcement Related to Off-Label Promotion

On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

FDA Panel Shows Strong Support for a Remicade Biosimilar

The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more

FDA’s Proposed Naming Convention for Biologics

On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more

12 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