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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The FDA released draft guidance on field alert reports, using a Q&A format to outline the responsibilities of drug applicants for FAR submissions.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
Biosimilar sponsors need to include the name of the reference product in labeling if the label includes clinical data derived from that product, the FDA said in a final guidance released Wednesday. Read More
FDA Commissioner Scott Gottlieb announced the release of a new action plan for biosimilars on Wednesday and said it would help prime the “anemic” biosimilar market. Read More
The senator asked if Pfizer will make the deferrals permanent if the White House’s drug pricing blueprint does not take effect during this calendar year. Read More