2005 Biosimilars Marketing Regulations 
FDA Law Blog: Biosimilars
SEPTEMBER 26, 2023
(HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). I’m incredibly excited by the opportunity to work for HP&M and its amazing group of professionals.
FDA Law Blog: Biosimilars
AUGUST 21, 2023
Investigators also found that the pharmacy sold pseudoephedrine (“PSE”) products but failed to self-certify in violation of the Combat Methamphetamine Act of 2005 (“CMEA”). Regulated sellers must renew their self-certification annually for each place of business where they sell SCLPs. We note that in December 2020, the same U.S.
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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. persons outside the United States in reliance on Regulation S under the Securities Act.
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.
The Pharma Data
AUGUST 13, 2020
person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.
The Pharma Data
AUGUST 13, 2020
person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.
The Pharma Data
NOVEMBER 9, 2020
The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. 2005; 172; 149–60.
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