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![USFDA Q&A Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products](https://static.wixstatic.com/media/nsplsh_71ca2ffbf66b4ec497ed3100fe48d6fd~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_71ca2ffbf66b4ec497ed3100fe48d6fd~mv2.webp)
Sharan Murugan
- 3 days ago
- 2 min
USFDA Q&A Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products
Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics...
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![USFDA Guidance: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers](https://static.wixstatic.com/media/nsplsh_535c7604c61640b482f3b2ae39b63c4d~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_535c7604c61640b482f3b2ae39b63c4d~mv2.webp)
Sharan Murugan
- Jul 9
- 2 min
USFDA Guidance: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers
The US Food and Drug Administration (FDA) issued a draft guidance for the industry yesterday titled “Addressing Misinformation About...
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![USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A](https://static.wixstatic.com/media/nsplsh_2d6171385274416a546549~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_2d6171385274416a546549~mv2.webp)
Sharan Murugan
- Apr 27
- 2 min
USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A
On 24 April 2026 (Wednesday) the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research released a...
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![USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know](https://static.wixstatic.com/media/6516fb_876b5d858d924c9e810ca51ea98124c0~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_876b5d858d924c9e810ca51ea98124c0~mv2.webp)
Sharan Murugan
- Feb 17
- 1 min
USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know
Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...
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![USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers](https://static.wixstatic.com/media/nsplsh_f2895b9f7aea4be79b1b1833a2bcb049~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_f2895b9f7aea4be79b1b1833a2bcb049~mv2.webp)
Sharan Murugan
- Jan 28
- 2 min
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...
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