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In its first annual report, the CDER Office of Communications pointed to its three main goals, all of which focus on supporting the public’s faith in the FDA to protect public health. Read More
Many drug developers could improve the alignment of their quality units and their business units — and potentially avoid Form 483 inspection observations — if they dusted off and applied the International Council on Harmonization’s ICH Q10 Pharmaceutical Quality System guidance, according to one pharma quality expert. Read More
In a JAMA commentary on the research paper, scholars wrote that production problems are responsible for 70 percent or more of shortages on record. Read More
Following ample input and data provided by the FDA, HHS has issued a white paper detailing its progress in reducing what it labels a “decades-long public health issue” — drug shortages and supply chain vulnerabilities. Read More
Most cancer drugs that gain an Accelerated Approval don’t end up showing any clinical benefit in their confirmatory trials, exposing thousands of patients to ineffective therapeutics that may linger on the market for years until postmarketing studies show their true clinical impact, a new analysis has shown. Read More
Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023, to keep you updated on laws and regulations that could impact your business. Read More
In this edition of Quick Notes, Vanda gets a new indication for its antipsychotic drug, Daiichi Sankyo and AstraZeneca get a new indication for their oncology drug, multiple myeloma patients can look to earlier use of drugs from Johnson & Johnson and Bristol Myers Squibb, and HHS funds support a new antibiotic approved for three serious infections. Read More
The FDA’s Office of Pharmaceutical Quality (OPQ) finished out 2023 by progressing in all four of its strategic priorities: collaboration, communication, engagement, and innovation, according to its 2023 annual report. Read More