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May 24, 2022

Santhigram Kerala Ayurvedic Co. of U.S., Inc. – 625892 – 05/19/2022

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Nair: This letter is to advise […]
May 24, 2022

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1)

Submit Comments by 07/24/2022 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
May 24, 2022

PETNET Solutions Inc. – 584016 – 05/17/2022

Product: Drugs Recipient: Recipient Name Mr. Barry Scott Recipient Title Chief Executive Officer PETNET Solutions Inc. 810 Innovation DriveKnoxville, TN 37932United States Issuing Office: Division of […]
May 24, 2022

PETNET Solutions Inc. – 584016 – 10/17/2019

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Barry Scott Recipient Title Chief Executive Officer PETNET Solutions Inc. 810 Innovation DriveKnoxville, TN 37932United States […]
May 23, 2022

Regulatory Health Project Manager Jobs in CDER

Description of duties Manage the drug review process for one or more classes of drugs. Plan, focus and coordinate team activities within the Division. Plan and […]
May 23, 2022

Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure

Summary Company Announcement Date: May 20, 2022 FDA Publish Date: May 23, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Dissolution Test Failure Company […]
May 23, 2022

Effects of Realistic In Vitro Test Factors on the Aerosol Properties of Metered-Dose Inhalers

Background Metered dose inhalers (MDIs) are drug-device combination products that use energy stored in a liquefied gas propellant, under pressure, for generating aerosols suitable for pulmonary […]
May 20, 2022

FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia

On May 20, 2022, the Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). Efficacy was […]
May 20, 2022

Clinical Investigator Training Course (CITC) Update – 12/07/2021

On This Page Date: December 7 – 8, 2021 Day1: Tue, Dec 7 1:00 PM – 5:00 PM ET Day2: Wed, Dec 8 1:00 PM – […]
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