The Pharma Data

APRIL 6, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Organon Finance 1 LLC plans to offer, subject to market conditions, euro-denominated senior secured notes due 2028, U.S. dollar-denominated senior secured notes due 2028 and U.S.

Regulations 52

Regulations Biosimilars Government Production 52

The Pharma Data

APRIL 8, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

Regulations 52

Regulations Biosimilars Government Production 52

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Labs must also begin complying with device labeling requirements (21 C.F.R.

Laboratories 64

Laboratories FDA Regulations Compliance 64

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. covered insulin product or vaccine). CMS also intends to implement a compliance monitoring program through future regulations or guidance. Final Guidance at 2. state pharmaceutical assistance programs).

Compliance 105

Compliance Pharmacy Drugs Licensing 105