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Two studies announced by the FDA today could eventually change the way drug manufacturers disclose risks and side effects in their print advertisements.
An SEC advisory committee has overwhelmingly recommended that the agency grant relief from Sarbanes-Oxley (SOX) reporting and auditing requirements for small companies, but the panel does not have the influence on the SEC that the pharmaceutical and biotechnology industries may believe, an agency spokesman says.
The FDA recently released guidance assisting applicants in meeting the electronic common technical document (eCTD) specifications when submitting electronic documents.
The FDA issued final guidance April 14 laying out the requirements companies must meet when submitting new drug applications (NDAs) for drugs to treat cystic fibrosis, chronic pancreatitis and pancreatic tumors, as well as those for patients who have undergone a pancreatectomy.
The FDA will soon implement a new policy formalizing presubmission reviews of drug applications to improve the drug pipeline by cutting down on both regulatory and industry inefficiency, Andrew von Eschenbach, the agency’s acting commissioner, says.
The FDA has issued a new guidance designed to help drugmakers identify compounds that could harm the immune system and provide direction on testing for such immunotoxicity.
The FDA issued final guidance April 14 laying out the requirements companies must meet when submitting new drug applications (NDAs) for drugs to treat cystic fibrosis, chronic pancreatitis and pancreatic tumors, as well as those for patients who have undergone a pancreatectomy.