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April 8, 2020

CPG Sec. 460.500 Prescription Drugs for Ship’s Medicine Chests

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: The question of supplying prescription-legend drugs for use […]
April 8, 2020

CPG Sec. 460.450 Status of Mail-Order Filling of Prescriptions

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: The question has been raised as to whether […]
April 8, 2020

CPG Sec. 460.425 Prescription Status when Telephoned to Recording Machine

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: Under Section 503(b) of the Act the dispensing […]
April 8, 2020

CPG Sec. 460.400 Computerized Prescription Recordkeeping by Pharmacies

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: The National Association of Boards of Pharmacy (NABP) […]
April 8, 2020

Q3C: Appendix 6

Docket Number: None found Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research APPENDIX 6. TOXICOLOGICAL DATA FOR […]
April 8, 2020

Designating an Orphan Product: Drugs and Biological Products

During this public health emergency associated with the COVID-19 pandemic, the Office of Orphan Products Development (OOPD) is providing sponsors with increased flexibility for submission of […]
April 8, 2020

October 30, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement – 10/30/2019 – 10/30/2019

On This Page Date: October 30, 2019 Time: 8:15 AM – 5:00 PM ET Center Date Time Location CDER October 30, 2019 8:15 a.m. to 5:00 […]
April 8, 2020

Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format

Docket Number: FDA-2014-D-1551 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 8, 2020

Pre-Launch Activities Importation Requests (PLAIR)

Docket Number: FDA-2013-D-0836 Issued by: Guidance Issuing Office Office of the Commissioner                                           Submit Comments You can submit online or written comments on any guidance at […]
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