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The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
Many of the guidance documents for drug developers and manufacturers that the FDA has issued during the COVID-19 pandemic are likely to continue to be in effect long after the public health emergency has passed, said Keith Webber, a former official in the FDA’s Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Read More
FDA investigators cited five drug facilities for failures ranging from late field reports to lax control of data, complaint handling and training. Read More
The FDA has developed two new documents that it wants drug sponsors to use for annual postmarket reporting and is requesting comments on them in a new draft guidance. Read More
The FDA issued warning letters to three drug manufacturing facilities for failures in their current good manufacturing practices, including lax environmental monitoring and inadequate process validations. Read More
Dr. Reddy’s Laboratories, one of India’s largest pharmaceutical companies, announced Thursday that it has temporarily shut down all of its data center services in response to a cyberattack. Read More
The Government Accountability Office (GAO) wants the FDA to institute several changes to its three-year-old Office of Laboratory Safety (OLS), which was formed to improve safety in the agency’s labs that work with hazardous biological agents. Read More
The FDA will not make COVID-19 vaccine developers go through pre-approval inspections for an Emergency Use Authorization (EUA), but companies will have to submit detailed manufacturing data and meet certain other requirements, said a senior official in the Center for Biologics Evaluation and Research (CBER). Read More
The FDA released a straight-to-final guidance on steps drugmakers should take to prevent high levels of nitrosamine impurities in their products. Read More
Drugs and biologics may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance on geriatric information for prescription product labeling. Read More
Five drugmakers drew warnings from the FDA for serious quality failures, including “superpotent” products, inadequate stability data and a lack of validation testing. Read More
Jack Garvey, founder and CEO of Compliance Architects, a firm specializing in GMP, quality and compliance services, calls for caution in applying the FDA’s new compliant-manufacturing resumption guidance.Read More