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March 31, 2020

Trilogy Laboratories, LLC – 595087 – 03/05/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Dr. Kristen K. Flaharty, PharmD Recipient Title Owner Trilogy Laboratories, LLC 10060 Amberwood Rd., Suite 1Fort Myers, […]
March 31, 2020

Coronavirus Treatment Acceleration Program (CTAP)

On this page FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move […]
March 31, 2020

Drug Trials Snapshots: SYMDEKO

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
March 30, 2020

Drug Trials Snapshot: PRALUENT

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
March 30, 2020

Drug Trial Snapshot: ONPATTRO

HOW TO USE THIS SNAPSHOTONPATTRO is a drug for the treatment of nerve damage in adult patients with hereditary transthyretin-mediated amyloidosis. The information provided in Snapshots […]
March 30, 2020

Guidance | Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act

The guidance Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, is intended to help manufacturers of certain drugs […]
March 30, 2020

Sunscreen meetings

On March 27, 2020, the President signed the Over-the-Counter Monograph Safety, Innovation, and Reform Act into law. This act is intended to modernize the process by […]
March 30, 2020

Drug Trials Snapshot: BIKTARVY

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
March 30, 2020

Drug Trial Snapshot: BRAFTOVI

HOW TO USE THIS SNAPSHOTBRAFTOVI is a drug which is to be used with another drug, binimetinib, to treat a type of skin cancer called melanoma. […]
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