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June 23, 2020

Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment

Docket Number: FDA-2009-D-0136 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research [Updated: 6/24/2020] Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment This guidance does […]
June 23, 2020

One Way Drug LLC dba Partell Specialty Pharmacy – 573455 – 06/16/2020

Product: Drugs Recipient: Recipient Name Robert A. Seik Recipient Title CEO, Owner One Way Drug LLC dba Partell Specialty Pharmacy 5835 S. Eastern Ave.Ste 101Las Vegas, […]
June 23, 2020

One Way Drug LLC dba Partell Specialty Pharmacy – 573455 – 03/13/2019

Product: Drugs Recipient: Recipient Name Robert A. Seik Recipient Title CEO & Owner One Way Drug LLC dba Partell Specialty Pharmacy 5835 S. Eastern Avenue, Suite […]
June 23, 2020

Scientific Public Private Partnerships and Consortia

The Role of Scientific Consortia in Drug Development Background Information The Critical Path Initiative (CPI), and the Strategic Plan for Advancing Regulatory Science Initiative seek to […]
June 23, 2020

Rapid Equine Solutions, LLC – 595556 – 06/12/2020

Delivery Method: VIA Electronic Mail Product: Animal & VeterinaryDrugs Recipient: Recipient Name Mr. Jaime Della Polla Recipient Title President and Owner Rapid Equine Solutions, LLC 31a […]
June 23, 2020

Nanobots Healthcare, LLC dba Assurance Infusion – 608360 – 06/12/2020

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Raghuveer R. Chintalapally, R.Ph. Recipient Title Owner Nanobots Healthcare, LLC dba Assurance Infusion 2626 South Loop […]
June 22, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 22, 2020

For Immediate Release: June 22, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 22, 2020

FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma

On June 22, 2020, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) for adult patients with relapsed or refractory diffuse large […]
June 22, 2020

Complex Innovative Trial Designs Pilot Program Frequently Asked Questions

Response: Officially launched with the publication of a Federal Register Notice in August 2018, the CID Pilot Meeting Program is a U.S. Food and Drug Administration […]
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