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…
Labeling for oncology radiopharmaceuticals must include information on the potential for genotoxicity and adverse reproductive toxicity, the FDA said in new draft guidance. Source: Drug Industry Daily
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…
The FDA hit Surmasis Pharmaceutical of Des Moines, Iowa with a Form 483 after a February inspection revealed problems with laboratory records, computer systems and equipment inspections. Source: Drug Industry…
The “tangled web” of drug supply and payment chains benefits all the players except consumers, according to a Senate Finance Committee minority report. Source: Drug Industry Daily
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…
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…
Australia’s Therapeutic Goods Administration has updated its plan for mandatory drug shortage reporting based on public comments in response to an April request. Source: Drug Industry Daily
Novartis and BIO sent feedback to the FDA about its draft guidance on developing treatments for severely debilitating or life-threatening (SDLT) hematologic disorders, urging the agency to broaden its guidance.…
Chinese API manufacturer Henan Lihua drew a warning from the FDA over serious testing violations, inaccurate records and drug quality failures at its facility in Anyang, Henan. Source: Drug Industry…