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HHS Drug Pricing Disclosure Rule: Chance at a Renewed Life Following District Court Appeal?

USA - August 26 2019 Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court. On August 21, 2019, the U.S. Department of Health and Human...

Elizabeth K. Conti.

Pharmaceutical Companies Object to HHS Drug Pricing Disclosure Rule

USA - July 1 2019 Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and...

Elizabeth K. Conti.

OIG Report Finds a Small Percentage of Hospitals Do Not Obtain Compounded Drugs from FDA-Registered Outsourcing Facilities

USA - June 17 2019 On June 6, 2019, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report that found that, among a sample U...

Elizabeth K. Conti.

Cannabis-Derived Ingredients in FDA-Regulated Products: More Questions than Answers at FDA’s May 2019 Public Hearing

USA - June 3 2019 As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a...

FDA Finalizes Guidance on Biosimilar Interchangeability, Reiterates Case-by-Case Approach to Data Requirements

USA - May 16 2019 On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate...

Elizabeth K. Conti.