A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient safety issue in generic prostate cancer bicalutamide tablets produced by Intas and Sun at facilities in India.
FDA warns Canada’s Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firm’s manufacturing of over-the-counter drugs.
A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient safety issue in generic prostate cancer bicalutamide tablets produced by Intas and Sun at facilities in India.
FDA warns Canada’s Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firm’s manufacturing of over-the-counter drugs.
North Dakota State University economist Raymond March faults the way in which FDA provides risk management guidance to regulated companies.
A cancer center precision medicine expert calls on FDA to require labeling changes for some non-small cell lung cancer immune checkpoint inhibitors to reflect emerging evidence that they are inappropriate for some populations.
