Edition:
India

ADMA Biologics Says FDA declined to approve re-launch of Bivigam


Thursday, 20 Dec 2018 

Dec 19 (Reuters) - ADMA Biologics Inc ::ADMA BIOLOGICS PROVIDES REGULATORY UPDATE ON BIVIGAM® PAS SUBMISSIONS.ADMA BIOLOGICS INC - FDA ISSUES COMPLETE RESPONSE LETTER FOR PAS DRUG SUBSTANCE, APPROVES PAS FOR DRUG PRODUCT.ADMA BIOLOGICS INC - CRL DID NOT CONTAIN ANY REQUESTS FOR ADDITIONAL MANUFACTURING RUNS.ADMA BIOLOGICS INC - BELIEVES FDA COMMENTS TO DRUG SUBSTANCE PAS SUBMISSION ARE ADDRESSABLE AND RESOLVABLE.ADMA - FDA DIDN'T REQUEST ANY INFO PERTAINING TO COMPLIANCE STATUS, CLINICAL STUDY SAFETY, OTHERS ABOUT 3RD PARTY CONTRACT MANUFACTURERS AND VENDORS.ADMA BIOLOGICS INC - WILL REQUEST A MEETING WITH FDA AND PLANS TO PROMPTLY PROVIDE FDA WITH CLARIFICATION AND RESPONSES TO ISSUES RAISED IN CRL. 

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18 Apr 2019