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Imports › New Regulations › Pharmaceutical Industry

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

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

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

Mintz - Health Care Viewpoints on

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

McDermott Will & Schulte

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Schulte on

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

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