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![Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation](https://static.wixstatic.com/media/nsplsh_6d31487134696250397263~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_6d31487134696250397263~mv2.jpg)
Sharan Murugan
- Jun 9
- 2 min
Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical...
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![USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products](https://static.wixstatic.com/media/6516fb_26f61cdb277d45c7a55d3276bdeb610f~mv2.jpg/v1/fill/w_399,h_213,fp_0.50_0.50,q_90,enc_auto/6516fb_26f61cdb277d45c7a55d3276bdeb610f~mv2.jpg)
Sharan Murugan
- Sep 21, 2023
- 2 min
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products
The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft...
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![USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information](https://static.wixstatic.com/media/nsplsh_d18c17b5ec374655babcca256f9533a1~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_d18c17b5ec374655babcca256f9533a1~mv2.jpg)
Sharan Murugan
- Sep 10, 2023
- 2 min
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
Recently on 05 September 2023, the United States Food & Drug Administration's Center for Drug Evaluation and , Research, Center for...
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![USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products](https://static.wixstatic.com/media/6516fb_5729f12f4b4f448b9de0104f5b49b907~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_5729f12f4b4f448b9de0104f5b49b907~mv2.jpg)
Sharan Murugan
- Aug 10, 2023
- 2 min
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...
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![USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants](https://static.wixstatic.com/media/6516fb_43f4b4c403274bc88ea59cf06b70d2c9~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_43f4b4c403274bc88ea59cf06b70d2c9~mv2.jpg)
Sharan Murugan
- Feb 19, 2023
- 2 min
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...
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