Some revisions are needed for the draft guidance on formal meetings between the FDA and sponsors of biosimilar products, the Generic Pharmaceutical Association said. "Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants" must be clarified to guarantee a full understanding of the requirements and expectations of the FDA, the group said. It added the FDA should explain if a request for a first biosimilar advisory meeting can be rejected and give guidance on such situations.
GPhA: FDA should revise draft guidelines on biosimilar meetings
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