What is the RDRC Program? The Radioactive Drug Research Committee (RDRC) program began when the Food and Drug Administration published a Federal Register notice on July […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-02-01 Product: Drugs Recipient: Recipient Name Jack Oswald Recipient Title CEO ISOThrive, Inc. 2165 Toyon […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-40 Product: Drugs Recipient: Recipient Name Ren Zhongju Chengdu Innovation Pharmaceutical Co., Ltd. No.123, 1st Floor, No 91 Zhongheng […]

Delivery Method: Via Electronic Mail Return Confirmation Requested Reference #: 320-25-38 Product: Drugs Recipient: Recipient Name Ms. Hongwei Xu Recipient Title General Manager Wuhu Nuowei Chemistry […]

Delivery Method: Via Electronic Mail Return Confirmation Requested Reference #: 320-25-37 Product: Drugs Recipient: Recipient Name Mr. Sudheer Kancherla Recipient Title Chief Executive Officer Strukmyer LLC […]

Frequently Asked Questions (FAQs) What is the right time for a drug developer/sponsor to apply for MIDD? MIDD approaches can add value throughout drug development; therefore, […]

Exceptions or additions to the recognized standards S = Susceptible; I = Intermediate; R = Resistant   Minimum Inhibitory Concentrations (mcg/mL)  Disk Diffusion (zone diameters in […]

[embedded content]   Espanol First comes the itching, then a red rash, and then blisters. These symptoms of poison ivy, poison oak, and poison sumac can emerge […]

Docket Number: FDA-2011-D-0720 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Implementation of ICH E2B(R3) The E2B(R3) document package comprises four materials. The […]