The Knowledge Shelf

US FDA

Section 804 Importation Program Policies and Authorizations
ByDossier Experts March 6, 2026

FDA has issued policies and taken actions to implement section 804 of the Federal Food, Drug and Cosmetic Act, which allows states and Indian tribes to import certain prescription drugs from Canada. Learn more.

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US FDA

FDA Holds Meeting with States on Importation of Lower Cost Drugs
ByDossier Experts March 6, 2026

FDA held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer.

Read More FDA Holds Meeting with States on Importation of Lower Cost Drugs
US FDA

Wound and Burn Dressing Recall: Integra LifeSciences Removes Certain MediHoney and CVS Wound and Burn Products
ByDossier Experts March 6, 2026

Integra is removing certain Wound and Burn Dressing products that may have breached sterile barriers.

Read More Wound and Burn Dressing Recall: Integra LifeSciences Removes Certain MediHoney and CVS Wound and Burn Products
MHRA

Precautionary recall of blood pressure medication after packaging error
ByDossier Experts March 6, 2026

The MHRA has advised pharmacy and healthcare professionals to return all remaining stock to their suppliers

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MHRA

Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 5mg capsules, EL(26)A/11
ByDossier Experts March 6, 2026

Crescent Pharma Limited is recalling one batch of Ramipril 5 mg Capsules as a precautionary measure due to a potential error at the manufacturing site.

Read More Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 5mg capsules, EL(26)A/11
MHRA

MHRA phase I accreditation scheme
ByDossier Experts March 6, 2026

How to join the phase I accreditation scheme.

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US FDA

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection
ByDossier Experts March 6, 2026

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection

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MHRA

COVID-19 test approval: how to apply
ByDossier Experts March 6, 2026

How manufacturers or distributors of Coronavirus (COVID-19) test devices can apply for approval of their tests to be placed on the UK market.

Read More COVID-19 test approval: how to apply
US FDA

Maiva Pharma Private Limited – 2/20/2026
ByDossier Experts March 6, 2026

Maiva Pharma Private Limited – 2/20/2026. Country: India. Record Type: 483

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US FDA

Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
ByDossier Experts March 5, 2026

Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis

Read More Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
US FDA

Catheter Recall: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
ByDossier Experts March 5, 2026

Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis.

Read More Catheter Recall: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
US FDA

Activities Report of the Generic Drug Program (FY 2025) – FDARA Title VIII Sections 807 and 805
ByDossier Experts March 5, 2026

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).

Read More Activities Report of the Generic Drug Program (FY 2025) – FDARA Title VIII Sections 807 and 805