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FDA Commissioner Scott Gottlieb announced a revised agreement between the agency and states on interstate distribution of compounded drugs, responding to concerns that the existing distribution limits are too low. Read More
FDA Commissioner Scott Gottlieb said the agency plans to scrap its existing guidance on developing new pain drugs and replace it with guidances designed to promote development of new opioid alternatives and improve benefit and risk assessments of new opioid drugs in the works. “Everything is on the table,” Gottlieb said in announcing the move aimed at driving innovation for fresh options to the potent, addictive pain meds. He noted the initiative will include at least four new guidances. Read More
The FDA released final guidance for drug sponsors on the content and formatting of physiologically-based pharmacokinetic (PBPK) analyses, including an expanded section on formatting and a simplified section on software. Read More
Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to win FDA approval, the agency says in a new draft guidance. Read More
Sponsors conducting nonclinical radiopharmaceutical diagnostic drug trials can seek waivers for specific nonclinical pharmacology or toxicology studies, according to final guidance from the FDA. Read More
Merck and GlaxoSmithKline called for more information from the FDA in comments on the agency’s draft guidance for sponsors using the limited population pathway for antibacterial and antifungal drugs (LPAD). Read More
The FDA’s draft guidance on inclusion of adolescents in adult oncology clinical trials should clarify how the agency’s thinking aligns with international regulations, stakeholders said in comments on the June 1 draft. Read More
The FDA issued new guidance for sponsors of drugs designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies. In a pair of final guidances, the agency urges drug sponsors to focus on real-world settings when trying to determine doses. Read More
The FDA issued guidance on how sponsors of synthetic drugs should approach post-approval manufacturing process changes — listing examples of low, medium and high risk changes. Read More
The FDA issued final guidance on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances. Read More