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SECTIONIALL INDIA INSTITUTE OF MEDICAL SCIENCES ANSARI NAGAR, NEW DELHI110 029 NOTICE INVITING TENDERS (NIT)Advertised Limited Tender Enquiry No: 53/H/Exon Skipping Of Exon 45 ( Inj. Casimersen )/
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What is sarepta announces fda acceptance?
Sarepta Therapeutics announced that the FDA has accepted its new drug application for review, indicating that the agency will evaluate the drug's safety and efficacy for potential approval.
Who is required to file sarepta announces fda acceptance?
Sarepta Therapeutics, as a pharmaceutical company seeking FDA approval for its drug, is responsible for filing the necessary documentation.
How to fill out sarepta announces fda acceptance?
Sarepta Therapeutics follows specific guidelines outlined by the FDA, completing the necessary forms and providing comprehensive data on the drug's clinical trials, safety profile, and labeling.
What is the purpose of sarepta announces fda acceptance?
The purpose is to notify stakeholders and the public that the FDA has acknowledged the submission, which is a step towards possible market approval for the drug.
What information must be reported on sarepta announces fda acceptance?
The report must include information about the drug's clinical trial results, proposed labeling, manufacturing processes, and information regarding its safety and efficacy.
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