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June 12, 2020

Jubilant DraxImage Radiopharmacies, Inc. – 480877 – 06/04/2020

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Wayne Alexander, MBA Recipient Title Director, Quality Jubilant DraxImage Radiopharmacies, Inc. Triad Isotopes Inc. 4205 Vineland […]
June 12, 2020

Central Admixture Pharmacy Services Inc – 497021 – 05/27/2020

Product: Drugs Recipient: Recipient Name Thomas J. Wilverding Recipient Title President Central Admixture Pharmacy Services Inc 6800 Aston StreetSuite 150Irvine, CA 92606United States Issuing Office: Division […]
June 11, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 11, 2020

For Immediate Release: June 11, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 11, 2020

CPG Sec. 160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs – Reconditioning

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: The question has arisen as to whether drug and device products that have been produced or […]
June 11, 2020

CPG Sec. 160.600 Payment of Expert Witnesses

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: FDA Staff Manual Guide 2610.2 sets *limits for expert witness court appearance fees* in a Food […]
June 11, 2020

FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord

For Immediate Release: June 11, 2020 The U.S. Food and Drug Administration today approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica […]
June 11, 2020

CPG Sec. 160.500 Answering Inquiries on Status of Criminal Referrals

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: Potential criminal cases are frequently preceded by an opportunity for proposed defendants to present their views […]
June 11, 2020

CPG Sec. 160.400 *Section 305 Meeting* Before Report of Criminal Violation

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: Section 305 of the Act states: “Before any violation of this Act is reported by the […]
June 11, 2020

CPG Sec. 160.300 Requests for Records Under Section 703

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: *Questions have existed among the field districts regarding the existence and extent of their authority to […]
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