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![EU MDCG: Revised Device Surveillance Guidance](https://static.wixstatic.com/media/nsplsh_556b557a3135527a6b6963~mv2_d_12000_8000_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_556b557a3135527a6b6963~mv2_d_12000_8000_s_4_2.jpg)
Sharan Murugan
- May 31
- 2 min
EU MDCG: Revised Device Surveillance Guidance
Medical Device Coordination Group (MDCG) released a second revision to its Surveillance Guidance for Medical Devices, aligning it with EU...
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![ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines](https://static.wixstatic.com/media/nsplsh_b58e90a363cf472d88b6f4f10478df62~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_b58e90a363cf472d88b6f4f10478df62~mv2.jpg)
Sharan Murugan
- May 31
- 2 min
ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...
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![USFDA Guidance: Platform Technology Designation Program for Drug Development](https://static.wixstatic.com/media/nsplsh_433859464d71474f764877~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_433859464d71474f764877~mv2.jpg)
Sharan Murugan
- May 28
- 2 min
USFDA Guidance: Platform Technology Designation Program for Drug Development
Today (29 May 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
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![Malaysia NPRA: Electronic Labelling (E-Labelling) Guidance For Pharmaceutical Products](https://static.wixstatic.com/media/6516fb_4e0f508b3bce47529530647b38c335e3~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_4e0f508b3bce47529530647b38c335e3~mv2.jpg)
Sharan Murugan
- May 25
- 2 min
Malaysia NPRA: Electronic Labelling (E-Labelling) Guidance For Pharmaceutical Products
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (21 May, 2024) released an updated guideline on " Electronic...
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![EDQM Guidance: Content of the Dossier for Sterile Substances](https://static.wixstatic.com/media/nsplsh_515475374653744b344145~mv2_d_3140_2093_s_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_515475374653744b344145~mv2_d_3140_2093_s_2.jpg)
Sharan Murugan
- May 25
- 2 min
EDQM Guidance: Content of the Dossier for Sterile Substances
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released a draft guideline titled "Content of the Dossier...
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