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![Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA](https://static.wixstatic.com/media/nsplsh_5f4876554e35786c763749~mv2_d_12000_8028_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_5f4876554e35786c763749~mv2_d_12000_8028_s_4_2.webp)
Sharan Murugan
Jun 19, 20211 min read
Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA
This is a DRAFT GUIDANCE distributed for comment purposes only. This guidance provides recommendations to sponsors for the collection of...
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![FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments](https://static.wixstatic.com/media/nsplsh_ebcea813c4324287a70a81e29d056d4a~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_ebcea813c4324287a70a81e29d056d4a~mv2.webp)
Sharan Murugan
Jun 11, 20211 min read
FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments
The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...
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![FDA Guidance regarding Onsite Inspections during COVID19 (Q&A) - USA](https://static.wixstatic.com/media/nsplsh_6a322af9fabd424f9518675ae2528c50~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_6a322af9fabd424f9518675ae2528c50~mv2.webp)
Sharan Murugan
May 28, 20211 min read
FDA Guidance regarding Onsite Inspections during COVID19 (Q&A) - USA
After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug...
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![ANDAs for Certain Highly Purified Synthetic Peptide Drug Products](https://static.wixstatic.com/media/nsplsh_c347636f27134e099a02845f507f71dc~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_c347636f27134e099a02845f507f71dc~mv2.webp)
Sharan Murugan
May 28, 20211 min read
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products
The guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product...
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![FDA Offers guidance on Generic Drug Development- COVID](https://static.wixstatic.com/media/nsplsh_f95c7a912fa442eaae8259e76ea37361~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_f95c7a912fa442eaae8259e76ea37361~mv2.webp)
Sharan Murugan
May 4, 20211 min read
FDA Offers guidance on Generic Drug Development- COVID
US Food and Drug Administration (FDA) On April-5, 2021 released new questions and answers guidance for generic drug makers briefing...
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