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Review for Regulatory Action Date From Subject NDA # Applicant Name Date of Submission PDUFA Goal Date Proprietary Name / Established (USAN) Name Dosage Forms / Strength Proposed Indication Action: March 1, 2010 Bob A. Rappaport, M.D. Director Division of Anesthesia, Analgesia and Rheumatology Products Division Director Summary Review 21217 ALZA Corporation Original: December 28, 1999 AE: October 27, 2000 Resubmission: May 22, 2009 March 1, 2010 HCl Extended Release 8 mg,.
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Oros FAQ
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The Brief Summary is a monthly bulletin intended for all Office of Prescription Drug Promotion (OPDP) stakeholders. The Brief Summary provides news and updates related to OPDP.
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trial or the intent of conducting such a trial and the term effectiveness refers to the regulatory determination that is made on the basis of clinical efficacy and other data.
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SBAs are prepared when the drug is released for use in the practice of medicine. Properties: Safety, efficacy, effectiveness. Selection process: The CDB has criteria that determine which drugs justify an SBA. No one can request that an assessment be done beyond the intended target group of a given drug.
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The Brief Summary is a monthly bulletin intended for all Office of Prescription Drug Promotion (OPDP) stakeholders. The Brief Summary provides news and updates related to OPDP.
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The ISE is a comprehensive integrated analysis of the effectiveness of a study drug. The purpose of the ISE is to describe the available information regarding effectiveness, delineate strengths and weaknesses, and highlight important missing information.
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Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) are Regulatory submission documents which are required to be submitted to the Food and Drugs Administration (FDA) while filing a New Drug Application (NDA).
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The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes: Who should not take the drug. When the drug should not be taken.
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The SSED is an FDA document intended to present a reasoned, objective, and balanced summary of the scientific evidence, both positive and negative, that served as the basis of the decision to approve or deny the PMA.
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