fbpx
April 22, 2020

Public Notification: OrgaZEN Gold 5800 contains hidden drug ingredient

[2-5-2020] The Food and Drug Administration is advising consumers not to purchase or use OrgaZEN Gold 5800, a product promoted and sold for sexual enhancement on […]
April 22, 2020

Animal Models — Essential Elements to Address Efficacy Under the Animal Rule_09

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
April 22, 2020

Animal Models — Essential Elements to Address Efficacy Under the Animal Rule – Concept Paper

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
April 22, 2020

Medical Countermeasure Monitoring and Assessment

Image CaptionElectronic health records are an important part of post-dispensing medical countermeasure monitoring and assessment Background | FDA Guidance & Regulatory Information | Contact | FDA […]
April 22, 2020

ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information

Docket Number: FDA-2004-D-0182 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Chemistry, manufacturing, and controls (CMC) information […]
April 22, 2020

Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is being issued to […]
April 22, 2020

ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

Docket Number: FDA-2014-D-0547 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides answers to questions […]
April 22, 2020

ANDAs: Impurities in Drug Substances

Docket Number: FDA-1998-D-0021 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides revised recommendations on […]
April 22, 2020

ANDAs: Impurities in Drug Products

Docket Number: FDA-2010-D-0584 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides recommendations on what […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0