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.

Pharmacy 52

Pharmacy Regulations Production Laboratories 52

The Pharma Data

APRIL 6, 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

SEPTEMBER 26, 2023

Jeff’s knowledge of FDA and regulated industry along with his prior experience will help us ensure that companies and individuals who need our expertise understand the depth and breadth of our services,” said J.P. Ellison, HP&M’s Managing Director.

Marketing 59

Marketing Compliance Science FDA 59

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

MAY 23, 2023

Specifically, field staff are advised to pay close attention to situations where allergen cross-contact may occur because of poor current good manufacturing practices (cGMPs), inadequate preventive controls, or inadequate controls under the juice or seafood HACCP regulations.

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FDA Compliance Regulations Production 45

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.

Production 52

Production Government Regulations Marketing 52

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.

Production 52

Production Government Marketing Regulations 52