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Licenses Manufacturers Pharmaceutical Industry

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer

On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas) for marketing...more

Troutman Pepper

FTC Finalizes Amendments To HSR Rules Regarding Transfer Of Exclusive Patent Rights In The Pharmaceutical Industry

Troutman Pepper on

The Federal Trade Commission (FTC) has finalized certain amendments to the Hart-Scott-Rodino (HSR) premerger notification regulations clarifying the scope of reportable transactions involving transfers of patent rights in the...more

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