The FDA’s effort to expedite reviews for drugs in line with the Trump administration’s priorities was greeted warmly by a pharmaceutical industry interested in moving approvals more quickly, but raised concerns about the scope of the plan in light of recent cuts at the agency. The pharmaceutical industry benefits from the decreased review time for drugs and biologics. The strenuous process involves the FDA analyzing thousands of pages of an application while being in constant communication with sponsors to ensure a drug is safe and effective along with the facilities where it’s manufactured. “This program, if successful, can inform the next generation of product development priorities,” said Julie Tibbets, chair of Goodwin’s Life Science Regulatory and Compliance practice. “If the commissioner can create speed to market for the initial programs as a test case, that has the potential to lift industry as a whole.”
Read the Bloomberg Law article for more.