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CDER launched two new efforts to gather feedback about the use of quality metrics in modernizing drug quality systems, calling for participants in a voluntary pilot program and encouraging meeting requests. Read More
Labeling for oncology radiopharmaceuticals must include information on the potential for genotoxicity and adverse reproductive toxicity, the FDA said in new draft guidance. Read More
The FDA released guidance on the agency’s BsUFA II fee structure Thursday finalizing the changes introduced since BsUFA I — including that biosimilars will no longer be assessed supplemental or establishment fees and the number of program fees per year will be limited to five per company. Read More
The “tangled web” of drug supply and payment chains benefits all the players except consumers, according to a Senate Finance Committee minority report. Read More
Drug manufacturers in New York may soon be required to fund and operate take-back programs to dispose of unused drugs, as the state’s legislature voted unanimously last week to send legislation to the governor’s desk. Read More
Illicit online sales of addictive substances are filling the gap created by successful efforts to reduce legal opioid prescriptions, FDA Commissioner Scott Gottlieb said Wednesday at an agency-hosted summit on reducing the availability of illicit opioids online. Read More
“While we understand that this Draft Guidance is specific to severely debilitating or life-threatening hematologic disorders, BIO believes it could be used as a model for other disease areas,” the industry group said in a written statement. Read More