BioPharm International
March 15, 2020
Resources
2020 eBook
2
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
March 15, 2020
Resources
2020 eBook
2
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
March 15, 2020
Regulatory Update
2020 eBook
2
With some FDA inspections on hold, will the US drug supply maintain its quality standards?
March 15, 2020
Pharmacopoeia Compliance Series
2020 eBook
2
Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.
March 15, 2020
Pharmacopoeia Compliance Series
2020 eBook
2
This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.
March 15, 2020
Pharmacopoeia Compliance Series
2020 eBook
2
This article returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.
March 15, 2020
Gene and Cell Therapies
2020 eBook
2
In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.