Showing 33–48 of 155 results

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  China’s NMPA: List of the First Batch of Rare Diseases

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  CRITERIA FOR CONDUCTING STABILITY STUDIES FOR ACTIVE PHARMACEUTICAL INGREDIENTS AND NON-BIOLOGICAL DRUGS

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  FDA : Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) (2020)

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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 : Acceptance and Filing Review for PMAs

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  FDA Guidance: 510(k)-Review-Program (2020)

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  FDA Guidance: ANDA Submissions —Content and Format (2018)

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  FDA Guidance: Annual Reports for Approved Premarket Approval Applications (PMA) (2019)

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  FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs — General Considerations (2019)

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  FDA Guidance: Cosmetic Good Manufacturing Practices (2013)

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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: Providing Regulatory Submissions for Medical Devices in Electronic Format (2020)

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  FDA Guidance: Referencing Approved Drug Products in ANDA Submissions

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