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Novartis, BIO Seek Broader Use of Hematological Nonclinical Draft Guidance

Posted 26 June 2018 | By Zachary Brennan 

Novartis, BIO Seek Broader Use of Hematological Nonclinical Draft Guidance

Recent FDA draft guidance on the preclinical development of treatments for severely debilitating or life-threatening hematologic disorders could serve as a model for guidance in other disease areas, both biopharma company Novartis and industry group BIO said in recently released comments.

BIO applauded FDA’s draft, which seeks a “streamlined nonclinical program,” saying it supports FDA’s goal of getting safe and effective products to patients and avoiding the unnecessary use of animals.

“While we understand that this Draft Guidance is specific to severely debilitating or life-threatening hematologic disorders (SDLTHDs), BIO believes it could be used as a model for other disease areas,” the group said.

Similarly, Novartis said: “We would like to see this guidance applied in a much broader way helping patients in all diseases that fall into this category (SDLT) and not restricting it to only hematologic disorders.”

Both Novartis and BIO also offered more specific line-by-line comments on specific sections. For instance, Novartis sought more information on whether “a life-threatening disease with a limited expected survival time would justify an approach similar to cancer patients as referred to in ICH S9, i.e. that clinical trials can be conducted without any genotoxicity tests available.”

BIO further noted that most of the conditions cited in the draft are SDLTHDs and rare diseases.

“It would be helpful to include additional examples of more common SDLTHDs in the list of examples to alleviate the potential concern that this approach is only relevant to disorders that are severely debilitating or life-threatening and meet the definition of a rare disease,” BIO said.

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