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Biological medicinal products have become the promising solutions in the prevention and treatment of several life-threatening, chronic diseases and health conditions. Realizing this scope, several pharmaceutical companies are venturing into producing biological products like never before.
As said and done for many times till now, the United Sates Food and Drug Administration (USFDA) has set a compliance deadline for eCTD (electronic common technical document) submissions. The deadline for the first phase is on 5th May 2017 and for the second phase, it is on 5th May 2018. What’s there to reconsider now?
Even though the eCTD (Electronic Common Technical Document) format has been in existence for nearly ten years, now it has become a focal point for pharmaceutical, biologic and generic drugs manufacturers because of the US FDA (Food & Drug Authority) mandate stating that all NDAs (New Drug Application), BLAs (Biologics License Applications) and ANDAs (Abbreviated New Drug Applications) must...
As we all are aware, the United States Food and Drug Administration’s (US FDA’s) electronic Common Technical Document (eCTD) requirement is nearing the deadline.
Are you planning for clinical or non-clinical studies post December 17, 2016? If yes, we suggest you take a look at Food and Drug Administration’s (FDA’s) study Data standards applicable for certain types of submissions to CDER and CBER.
Do you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017.
Recently FDA has confirmed announcement of a major and final rule of labeling coming in July 2016 that will entail new guidelines for updating labels of generic drugs in terms of safety information. Announcing this final rule, FDA intends to make the process of label update easier for generic drug companies.
Influence of Present Rule
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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