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provepharm-inc.-issues-voluntary-nationwide-recall-of-one-lot-of-phenylephrine-hydrochloride-injection,-usp,-10-mg/-ml-(pharmacy-bulk-package)-due-to-presence-of-particulate-matter Drug Test
  • January 24, 2025

Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter

Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10…
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Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatment

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  • January 24, 2025

CDER Small Business & Industry Assistance (SBIA)

A Comprehensive Resource for Information on Human Drug Development in Regulation
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  • January 24, 2025

CDER Small Business and Industry Assistance (SBIA) Learn

SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small…
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  • January 24, 2025

Pharmaceutical Quality Resources

FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs.
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Impact of Repeated Glucocorticoid Oral Administration on the Urinary Steroid Profile

The consumption of glucocorticoids does not significantly impact the steroid profile. Steroid profiles might be flagged due to glucocorticoid consumption…
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Impact of Repeated Glucocorticoid Oral Administration on the Urinary Steroid Profile

The consumption of glucocorticoids does not significantly impact the steroid profile. Steroid profiles might be flagged due to glucocorticoid consumption…
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  • January 23, 2025

CDERLearn

Training and Education for healthcare professionals, academia, and consumers from FDA’s Center for Drug Evaluation and Research
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  • January 23, 2025

CDER Manual of Policies & Procedures | MAPP

CDER’s Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures.
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  • January 23, 2025

Compounding Quality Center of Excellence | Engage with the Compounding Quality Center of Excellence

Engage with the Compounding Quality Center of Excellence