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“The policy and regulatory decisions that we make today are going to have a lot to do with whether we realize the promise for this new category of products,” Gottlieb said. Read More
Gottlieb stressed that the agency is “not proposing a change in the evidentiary standard needed for a product to be approved by the FDA as nonprescription.” Read More
The Office of New Drugs will gain an Office of Therapeutic Biologics and Biosimilars to bolster reviews of biosimilars and interchangeable products as well as biologics. Read More
Gottlieb said a working group will study how the agency would deem an access issue serious enough to require importation and ways to ensure safety and quality of imported drugs. Read More
FDA Commissioner Scott Gottlieb announced Thursday that the agency will consider allowing imports of some drugs that have seen major price increases in the United States. Read More
CDER Director Janet Woodcock released details of a major overhaul of four CDER offices Thursday aimed at improving the center’s ability to respond to new priorities. Read More
The proprietary name should be used in sections that cover risks and warnings of adverse events, such as boxed warnings, contraindications and the “drug interactions” section. Read More
The agency urged sponsors to use EHR or EDC systems so the relevant information “may be entered once at the point-of-care and used many times without manual re-entry or manual source data verification.” Read More
The FDA released draft guidance on field alert reports, using a Q&A format to outline the responsibilities of drug applicants for FAR submissions. Read More
Drug sponsors and investigators should work with organizations that offer either interoperable or integrated electronic health records or electronic data capture systems, the FDA said in a final guidance released Wednesday. Read More