In Brief: Biologics reporting changes
Biologics reporting changes: Public meeting will be held April 19 to discuss FDA's proposed rule on reporting changes to an approved application and for well-characterized biotech products. The proposed rule establishing three categories for biologics change reporting was issued on Jan. 29 ("The Pink Sheet" Feb. 19, T&G-12). Interested participants may contact CBER's Margaret Tart at (301) 827-2000. The meeting will begin at 8 a.m. in NIH's Masur Auditorium...
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