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February 13, 2023

Frequently Asked Questions About Drugs

 1. Is it legal to import medicines into the U.S. from other countries? No. The United States Federal Food, Drug, and Cosmetic Act (The Act) prohibits […]
February 10, 2023

17th Annual FDA/DIA Biostatistics Industry and Regulator Forum, 2023 – 03/29/2023

On This Page Date: March 29 – 31, 2023 The meeting will be held March 29 – March 31, 2023, as a virtual event DIA/FDA Biostatistics […]
February 10, 2023

Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

Docket Number: 2023-02962 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Pediatric Therapeutics Center for Drug Evaluation […]
February 10, 2023

Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

Thank you for joining us for another episode of the Guidance Recap Podcast. My name is Kylie Haskins, and I am today’s host. In this episode, […]
February 10, 2023

Aurobindo Pharma Limited – 577033 – 02/09/2023

Reference #: FEI 3004611182 Product: Drugs Recipient: Recipient Name Mr. K. Nithyananda Reddy Recipient Title Managing Director Aurobindo Pharma Limited Sy. No. 61-66, IDA, Pydibhimavaram, Ranasthalam […]
February 10, 2023

Aurobindo Pharma Limited – 577033 – 06/20/2019

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. N. Govindarajan Recipient Title Managing Director Aurobindo Pharma Limited Plot No. 2, Maitrivihar, AmeerpetHyderabad 500038TelanganaIndia Issuing […]
February 10, 2023

Pfizer Healthcare India Private Limited – 594972 – 02/08/2023

Reference #: FEI 3008316085 Product: Drugs Recipient: Recipient Name Mr. Albert Bourla Recipient Title Chairman and Chief Executive Officer Pfizer Healthcare India Private Limited Pfizer, Inc. […]
February 10, 2023

Pfizer Healthcare India Private Limited – 594972 – 03/25/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Albert Bourla Recipient Title Chairman and Chief Executive Officer Pfizer Healthcare India Private Limited 235 East […]
February 9, 2023

A Brief History of the Center for Drug Evaluation and Research

The Center for Drug Evaluation and Research (CDER), which assures that safe and effective drugs are available to the American people, has gone through a functional […]
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