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![Swissmedic Guidance: Temporary Authorisation to Use an Unauthorised Medicinal Product](https://static.wixstatic.com/media/nsplsh_224340b976184e958f52ae010d0ba7c1~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_224340b976184e958f52ae010d0ba7c1~mv2.jpg)
Sharan Murugan
- Dec 27, 2022
- 1 min
Swissmedic Guidance: Temporary Authorisation to Use an Unauthorised Medicinal Product
A temporary authorisation of use of an unauthorised medicinal product under restricted conditions can be granted to the sponsor of a...
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![USFDA Guidance: Controlled Correspondence Related to Generic Drug Development](https://static.wixstatic.com/media/6516fb_0568a1cdb24c4b34ace027eff21ca5f4~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_0568a1cdb24c4b34ace027eff21ca5f4~mv2.jpg)
Sharan Murugan
- Dec 27, 2022
- 1 min
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...
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![ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)](https://static.wixstatic.com/media/nsplsh_382d503132772d4e747767~mv2_d_6000_4000_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_382d503132772d4e747767~mv2_d_6000_4000_s_4_2.jpg)
Sharan Murugan
- Dec 27, 2022
- 2 min
ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...
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![SFDA MD Guidance: Requirements for Clinical Trials of Medical Device](https://static.wixstatic.com/media/6516fb_8594980e3a984f088b04677cede78239~mv2.png/v1/fill/w_399,h_300,fp_0.50_0.50,q_95,enc_auto/6516fb_8594980e3a984f088b04677cede78239~mv2.png)
Sharan Murugan
- Dec 27, 2022
- 2 min
SFDA MD Guidance: Requirements for Clinical Trials of Medical Device
Yesterday (26-December-2022) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Requirements for...
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![USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter](https://static.wixstatic.com/media/nsplsh_f8a01d8270014bd39544959e11dd9322~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_f8a01d8270014bd39544959e11dd9322~mv2.jpg)
Sharan Murugan
- Dec 15, 2022
- 1 min
USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter
Yesterday (14-December-2022), USFDA published the revised final guidance “Failure to Respond to an ANDA Complete Response Letter Within...
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