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![USFDA Statement: New Patient Medication Information - Medication Guide for Patients](https://static.wixstatic.com/media/nsplsh_b16347f16a6344c8af0cfc2df96bc4d5~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_b16347f16a6344c8af0cfc2df96bc4d5~mv2.jpg)
Sharan Murugan
- Jun 1, 2023
- 1 min
USFDA Statement: New Patient Medication Information - Medication Guide for Patients
Yesterday (31 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research (CDER) proposed a new...
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![EMA Guidance: Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources](https://static.wixstatic.com/media/nsplsh_abbe2a071f5e4b9f8a9ae128d7af8b86~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_abbe2a071f5e4b9f8a9ae128d7af8b86~mv2.jpg)
Sharan Murugan
- Sep 27, 2022
- 1 min
EMA Guidance: Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources
Earlier today (27-September-2022) EMA released draft guidance on the "Good Practice Guide for the use of the Metadata Catalogue of...
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![USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality](https://static.wixstatic.com/media/nsplsh_7a45303037534e67636445~mv2_d_3886_4743_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_7a45303037534e67636445~mv2_d_3886_4743_s_4_2.jpg)
Sharan Murugan
- Sep 14, 2022
- 2 min
USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality
Yesterday (13-September,2022) FDA published a new webpage to share the most recent research activities of the Center for Drug Evaluation...
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![USFDA Guidance: Changes to Disposable Manufacturing Materials, Clinical Pharmacology Considerations](https://static.wixstatic.com/media/nsplsh_168b5dff09f54b67b22884851b616dc9~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_168b5dff09f54b67b22884851b616dc9~mv2.jpg)
Sharan Murugan
- Jul 31, 2022
- 2 min
USFDA Guidance: Changes to Disposable Manufacturing Materials, Clinical Pharmacology Considerations
Multiple guidances were updated and released by the USFDA last week and had some important updates related to Drugs, Biologics, and...
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![India CDSCO Guidance: 3 IVD Draft Guidances for Consultation](https://static.wixstatic.com/media/nsplsh_ed04e4f4176940989f893cea42521f2e~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_ed04e4f4176940989f893cea42521f2e~mv2.jpg)
Sharan Murugan
- Jul 27, 2022
- 1 min
India CDSCO Guidance: 3 IVD Draft Guidances for Consultation
Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...
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