Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References Safety Announcement [02-17-2011] The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of…
FDA reminder to avoid concomitant use of Plavix (clopidogrel) and omeprazole
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FDA Statement on ASBMR report: Possible Increased Risk of Certain Types of Thigh Bone Fractures with Long-Term Bisphosphonates Use
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Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271
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Q3D Elemental Impurities
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Q11 Development and Manufacture of Drug Substances
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Q8, Q9, & Q10 Questions and Answers — Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)
2] The ICH Quality Implementation Working Group (Q-IWG) has prepared this Points to Consider document covering topics relevant to the implementation of ICH Q8(R2), Q9, and Q10, which supplement the existing guidance Q8, Q9, and Q10 Questions Answers [3] and workshop training materials [4] already produced by this group. They should be considered all together. The points…
Q8(R2) Pharmaceutical Development
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Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 14: Bacterial Endotoxins Test General Chapter
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Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Annex 13: Bulk Density and Tapped Density of Powders General Chapter
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