The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
5/29/2024
/ Abbreviated New Drug Application (ANDA) ,
Canada ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Imports ,
Intellectual Property Protection ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Supply Chain
The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more
5/15/2024
/ CA Supreme Court ,
Duty of Care ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Gilead Sciences ,
Healthcare ,
HIV ,
Life Sciences ,
Manufacturers ,
Negligence ,
Pharmaceutical Industry ,
Phase II ,
Product Defects ,
Summary Judgment
The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more
2/10/2022
/ Drug Distribution ,
Drug Wholesaling ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Licensing Rules ,
Life Sciences ,
Listing Standards ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Standards ,
Supply Chain
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
10/26/2021
/ Anti-Competitive ,
Biden Administration ,
Biosimilars ,
Biotechnology ,
Competition ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare Reform ,
Intellectual Property Protection ,
Life Sciences ,
Patent Ownership ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
USPTO