Page 1. 1 Accelerated Approval (AA) for Oncology Drug Products: ... Page 17. 17 Trial Design � Initial AA � Trial design for initial accelerated approval (AA) ...
Center for Biologics Evaluation and Research (CBER)
... Center for Biologics Evaluation and Research (CBER) under ... still submit as many materials as possible ... report information in labeling material that is ...
Center for Drug Evaluation (CDER)
We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated ...
PubMed
... 2 patients who received product for bleeding indications were rated �unable to ... operative period of major surgery, due in part to accelerated consumption. ...
Objectives. I examined the relationship between the Food and Drug Administration's (FDA's) use of special regulatory designations and the frequency with which labels of oncology drugs are revised to explore how the FDA's designation of products relates to product development and refinement.Methods. One hundred oncology drugs, designated by the FDA as ...
PubMed Central
... PARTICLE ACCELERATORS, *TRITIUM, *PRODUCTION ENGINEERING, FEASIBILITY STUDIES, PARTICLE ACCELERATOR TARGETS, HELIUM ...
DTIC Science & Technology
Product Approval: February 24, 2010 Approval letter and Package Insert, and March 26, 2010 Approval History. ...
... Descriptors : *BETATRONS. Subject Categories : PARTICLE ACCELERATORS. Distribution Statement : APPROVED FOR PUBLIC RELEASE. ...
... fifth birthday). Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply Press Release: August 19, 2009; Approval ...
The development of accelerator-driven systems involving the production of spallation neutrons will require extensive materials data on the response of structural components to the effects of the mixed charged particle and neutron fluxes. Failure to anticipate the potentially strong influence of radiation on material`s performance will most certainly lead ...
DOE Information Bridge
Approved for public release, distribution unlimited. Reverse Ion Acceleration by Laser-Matter Interaction ... Backward Ion acceleration ? He++ Position ...
... AFLURIA Product Approval Information. ... The following officers or employees of FDA participated in the decision to approve this application and consented to be ...
...Before approval of foreclosure and acceleration of the account, the approval...substances on the property. (2) Acceleration of account. Subject...signed receipt for at least one of these acceleration notices sent by certified mail is...
Code of Federal Regulations, 2011
For several decades, the FDA has undertaken many initiatives to improve the quality and safety of sterile drug products. In recent years, efforts have also been undertaken to accelerate the rate for application approval by adding earlier involvement of microbiology reviewers in drug development. Product and ...
... equivalence evaluation of approved applications in the Agency's publication, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) from ...
... Development of a linear accelerator for production of a bunched ... This accelerator was ... Calibration of an analyzing magnet intended to produce, by ...
... OF NUCLEAR REACTORS ON ELECTRON ... equations of reactor acceleration; solution of ... ELECTRIC POWER PRODUCTION, REACTOR KINETICS ...
... Title : AN ACCELERATED METHOD FOR MOISTURE DETERMINATION IN MEAT PRODUCTS AND MEDICAL PREPARATIONS. ...
Tritium contamination reduction in small ion accelerators for neutron production, discussing pumping
NASA Technical Reports Server (NTRS)
...2011-04-01 2011-04-01 false A.I.D. approval of acceleration of notes. 204.33 Section 204.33 Foreign Relations...CONDITIONS Covenants § 204.33 A.I.D. approval of acceleration of notes. Without the prior approval of A.I.D.,...
...2009-04-01 2009-04-01 false A.I.D. approval of acceleration of notes. 204.33 Section 204.33 Foreign Relations...CONDITIONS Covenants § 204.33 A.I.D. approval of acceleration of notes. Without the prior approval of...
Code of Federal Regulations, 2010
... Therapeutic Biological Products Approvals. ... For the latest approval information on therapeutic biological products regulated by CDER, please see Drugs@FDA. ...
Page 1. This report has been reviewed in the Office of Civil Defense and is approved for publication. Approval does not ...
The Energy Security Act of 1980 establishes a US Synthetic Fuels Corporation (USSFC) to oversee production, which will be financed by assistance to the private sector. The USSFC will function as a private financial institution, but will have a board of directors appointed by the president and approved by congress. The law establishes a 300-employee limit ...
Energy Citations Database
Changes in regulatory policy and legislative incentives to promote the development of drugs for rare diseases - orphan drugs - have led to increases in the number of orphan drug designations, but the rate of such products reaching the market remains frustratingly flat. This article highlights areas in which novel approaches could facilitate regulatory ...
... Accelerated approval (AA) allows approval on a less-established surrogate end point, one that is reasonably likely to predict clinical benefit. ...
... The second route to drug approval is accelerated approval (AA), which can be based on a surrogate endpoint that is considered reasonably likely to predict ...
... FDA Approves Thalomid (thalidomide) to Treat Multiple Myeloma. On May 26, 2006, the US Food and Drug Administration granted accelerated ...
As a condition of accelerated approval, subsequent randomized trials are required to verify and describe the clinical benefit of lapatinib in patients with metastatic breast cancer who have received prior treatment with trastuzumab.
Cancer.gov
... Under Subpart H, approval may be based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity ("Surrogate ...
... Title : Investigation of Ion Beam Production and Acceleration Using Linear Electron Beams and a Pulse Powered Plasma Focus. ...
