Containment Licensing Regulation Sales 
Pharma Packaging Solutions
JULY 17, 2023
Due to the sensitive nature of many biological products, there are strict federal regulations in place to ensure safe packaging and distribution. Here is a brief overview of biologics packaging and labeling requirements according to the Code of Federal Regulations. General Regulations (From Section 112.1)
Pharma in Brief
APRIL 13, 2021
The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Health Canada has also published a guidance document that contains additional information for drug sponsors.
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FDA Law Blog
NOVEMBER 1, 2023
Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.
Pharma in Brief
MARCH 21, 2022
3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 ( IO No. 3 also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim orders. 2’s flexibilities and contains no substantive updates. Interim Order No. 1 and IO No.
The Pharma Data
MARCH 30, 2021
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. These targeted drugs bind to markers or proteins over-expressed by certain tumors, or tumor-associated tissue, such as stroma. Disclaimer. Source link:[link].
The Pharma Data
DECEMBER 13, 2020
. Relay Therapeutics will receive $75 million upfront and is eligible to receive an additional $25 million in near-term payments and $695 million in additional potential milestones, plus royalties on global net product sales. sales and up to $410 million in additional ex-U.S. CAMBRIDGE, Mass., About RLY-1971.
FDA Law Blog
DECEMBER 14, 2023
Conceding that they may disagree whether legalization of recreational cannabis or cannabis use is a “net positive,” the governors agreed that the cannabis industry is permanent, that states have implemented “strong regulations,” and supporting the state regulated cannabis marketplace “is essential for the safety of the American people.”
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