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The FDA released an updated version of its 2013 Manual of Policies and Procedures (MAPP) outlining CDER’s procedures for determining pharmacologic classes for use in prescribing information for drugs. 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. Read More
FDA Commissioner Scott Gottlieb announced the release of a new action plan for biosimilars and said it would help prime the “anemic” biosimilar market. Read More
The FDA unveiled six new draft guidances outlining its latest thinking on the rapidly evolving field of gene therapy — and Commissioner Scott Gottlieb said the agency plans to work with product sponsors to help make the development and approval of innovative gene therapies more efficient. Read More
Sponsors are required to submit the guides in cases where certain information is necessary to prevent adverse effects and where adherence to directions is essential to a drug’s effectiveness. Read More
AstraZeneca has agreed to pay $110 million to settle two lawsuits filed against it by the state of Texas alleging the pharmaceutical giant deceitfully marketed two of its drug products to Texas Medicaid providers. Read More
Insys announced Wednesday it reached an agreement with the Justice Department to pay $150 million over five years to settle allegations that it bribed doctors to prescribe its fentanyl sublingual spray Subsys. Read More