USA Pharmaceuticals
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FDA : Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
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FDA Guidance: ANDA Submissions —Content and Format (2018)
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FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs — General Considerations (2019)
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FDA Guidance: Data Integrity and Compliance With Drug CGMP Questions and Answers
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FDA Guidance: Expedited Programs for Serious Conditions – Drugs and Biologics
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FDA Guidance: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
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FDA Guidance: Investigational New Drug Applications (INDs) —Determining Whether Human Research Studies Can Be Conducted Without an IND
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FDA Guidance: Referencing Approved Drug Products in ANDA Submissions
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FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
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FDA: Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
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FDA: Post-marketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
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US FDA Guidance: Best Practices in Developing Proprietary Names for Human Prescription Drug Products
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