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Class Action - FDA Information

FDA Announces Label and Indication Changes for the Antibiotic Ketek: FDA today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients. The changes include the removal of two of the three previously approved indications -- acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis -- from the drug's label.
Information about the Products We Regulate: Information about the Products We Regulate Contents On This Page New Prescription Drug Approvals Prescription Drug Information ...
Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA): Information for Healthcare Professionals Erythropoiesis Stimulating Agents (ESA) [Aranesp (darbepoetin), Epogen (epoetin alfa), and Procrit (epoetin alfa)] ...
OTC Labeling: Questions and Answers: OTC Labeling: Questions and Answers What is FDA announcing today? FDA has finalized its regulation that will require ...
Information for Healthcare Professionals: Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact): Information for Healthcare Professionals Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact) FDA ALERT [8/2007]: This Alert...
Early Communication About an Ongoing Safety Review: Omeprazole (Prilosec) and Esomeprazole (Nexium): Early Communication About an Ongoing Safety Review Omeprazole (Prilosec) Esomeprazole (Nexium) This information reflects FDA’s current analysis of...
Guidance for Industry and Review Staff: Labeling for Human Prescription Drugs ? Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information: Guidance for Industry and Review Staff Labeling for Human Prescription Drugs — Determining Established Pharmacologic Class for Use in the Highlights of...
Division of New Drugs and Labeling Compliance (DNDLC): ...
Vioxx (rofecoxib) Questions and Answers: Vioxx (rofecoxib) Questions and Answers 1. What action did Merck taketoday? Merckannounced a voluntary worldwide withdrawal of Vioxx ...

PDUFA REAUTHORIZATION PERFORMANCE: ...
Report on the Workshop "A Drug Quality System for the 21st Century: PQRI/FDA Report on the Workshop "A Drug Quality System for the 21 st Century," April 22-24, Washington, D.C. (prepared June 16, 2003) ...
Pharmaceutical cGMPS for the 21st Century ? A Risk-Based Approach: Second Progress Report and Implementation Plan: Pharmaceutical cGMPS for the 21 st Century ? A Risk-Based Approach: Second Progress Report and Implementation Plan Introduction On February 20, 2003, the Food and...
HUMAN DRUG CGMP NOTES: ...
CBER Research Project: Action of Growth Factors in Animal Development: CBER Research Projects Project Title Action of Growth Factors in Animal Development Principal Investigator Deborah Hursh Laboratory Laboratory of Immunology and Developmental Biology;...
CBER Research Project: The Role of the Protein-Tyrosine Phosphatase SHP-2 as a Positive Mediator of ErbB Receptor Signalling: CBER Research Projects Project Title The Role of the Protein-Tyrosine Phosphatase SHP-2 as a Positive Mediator of ErbB Receptor Signalling Principal Investigator G.R. Johnson Laboratory ...
CDER FIRST ACTION PERFORMANCE FOR RESUBMITTED NDAs: CDER FIRSTACTION PERFORMANCE FOR RESUBMITTED NDAs Data as of FY 2005 Close-Out Cohort CDER NO. SUBMITTED RF or WF ...
CDER FIRST ACTION PERFORMANCE FOR RESUBMITTED EFFICACY SUPPLEMENTS: CDER FIRSTACTION PERFORMANCE FOR RESUBMITTED EFFICACY SUPPLEMENTS Data as of FY 2005 Close-Out Cohort CDER ...

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