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Federal Register notice: FDA makes available a draft ICH guidance entitled M7(R2)Addendum: Application of the Principles of the IC...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance on clinical development recommendations for hepatitis B virus infect...[ Price : $8.95]
Bayer asks FDA to confirm that it will apply a 30-month stay to an Apotex ANDA for a generic form of Bayers Astelin nasal spray.[ Price : $8.95]
Minerva Neurosciences says FDA continues to have questions and concerns about its proposed NDA for roluperidone to treat negative ...[ Price : $8.95]
CBER director Peter Marks outlines ways in which FDA and other stakeholders could expedite the development of gene therapies.[ Price : $8.95]
FDA publishes a guidance to help sponsors develop drugs and biologics to treat chronic hepatitis B virus.[ Price : $8.95]
FDA publishes for comment a draft of revisions to the International Council for Harmonization M7 guideline on calculating compound...[ Price : $8.95]
Three drug companies comment on an FDA draft guidance on the labeling content and format of immunogenicity information in human pr...