Inside FDA’s New Gene and Cell Therapy Guidances

News
Article
Pharmaceutical TechnologyPharmaceutical Technology-03-15-2020
Volume 2020 eBook
Issue 1
Pages: 6-9

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.

Since 2017, FDA has approved four gene therapies, and regulators expect the number of gene and cell therapies under development to increase dramatically.

Read this article in Pharmaceutical Technology’s March 2020 Regulatory Sourcebook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 6–9

Citation

When referring to this article, please cite it as A. Shanley, “Inside FDA’s New Gene and Cell Therapy Guidances," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).

Articles in this issue
Guidelines_225.jpg
Resources, Guidelines, and Guidance Documents
Orgs_225.jpg
Regulatory and Standard Setting Organizations
PTebook0320_004-005_RegulatoryActionUpdate_Peters.gif
A ‘New Normal’ for Quality?
Pharmacopoeia 1_225.jpg
Monograph Development: Why and When to Participate (eBook)
Pharmacopoeia 3_225.jpg
Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon (eBook)
Pharmacopoeia 2_225.jpg
A Practical Approach to Pharmacopoeia Compliance (eBook)
PTebook_cellandgene.jpg
Inside FDA’s New Gene and Cell Therapy Guidances
PT ebook_ALCOA.jpg
ALCOA+ and Data Integrity
Recent Videos
US tariff rate rising , trade policy , business graph and dollars banknote , tax calculation change | Image Credit: © janews094 - stock.adobe.com
Related Content
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

European Pharmacopoeia Goes Digital

Susan Haigney
June 25th 2025
Article

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Pharmacist weighing chemical | Image Credit: © Kzenon - stock.adobe.com

Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

Paul L. Pluta;Nishant B. Thakar;Varanya Chaiyaperm
June 23rd 2025
Article

Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

BASF Opens GMP Manufacturing Facility in Michigan

Susan Haigney
June 19th 2025
Article

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

FDA Voucher Program Provides Shorter Drug Application Review Time

Susan Haigney
June 18th 2025
Article

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time.