Hundreds of biotech CEOs and leaders sent a formal letter to FDA Director Marty Makary urging regulatory predictability and warning that agency volatility threatens U.S. innovation. The industry appeal came as the FDA announced plans to hire more than 1,000 staff and launched a pilot communications program to give sponsors quicker, written clarifications from review teams. The companies argued for consistent scientific standards and predictable timelines; the FDA said hires and the email clarification channel aim to speed reviews and reduce sponsor uncertainty. The moves and the industry letter together underscore how governance, workforce capacity and agency communications are now major risk factors for drug development timelines.