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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. CBER regulates products under a variety of regulatory authorities: INDs for CBER-regulated products. Section 351(a) is the traditional pathway for approving biologics under the PHS Act. BLA process (CBER).

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Recon: W. VA opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

The Pharma Data

Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ). Canada’s regulator holds Johnson & Johnson vaccine over Emergent link ( NYTimes ). Six patients with dementia went to Mexico for an unproven gene therapy, a biotech CEO claims ( STAT ).