NEW TEXTS THIS WEEK - Drug Information Association

PROCRIT and EPOGEN (epoetin alfa), for the treatment of anemia associated with CRF,
including patients on dialysis (ESRD) and patients not on dialysis, for the treatment of
anemia related to therapy with zidovudine in HIV-infected patients, for the treatment of ...
(Abstract truncated to see more please, go to the document!)
USA - CEPH International Corporation, 21-Mar-22-Apr-2005: FDA 483
This 3-pages form FDA 483 was issued at the conclusion of an inspection of drug
manufacturer CEPH International Corporation in Carolina, Puerto Rico. The following
observations were reported: - Control procedures are not established which monitor the
output and validate the performance of those manufacturing processes that may be
responsible for causing ... (Abstract truncated to see more please, go to the document!)
USA - Congressional Testimony: Statement of Donald Mattison, M.D. (National
Institutes of Health) - "Programs Affecting Safety and Innovation in Pediatric
Therapies", 22-May-2007
This hearing was held by the U.S. House of Representatives Committee on Energy and
Commerce's subcommittee on Health. In this testimony, Dr. Donald Mattison, Chief of
Obstetric and Pediatric Pharmacology Branch at NIH's National Institute of Child Health and
Human Development, discusses NIH's research activities in relation to implementation of
the ... (Abstract truncated to see more please, go to the document!)
USA - Congressional Testimony: Statement of Lori M. Reilly (Pharmaceutical
Research and Manufacturers of America) - "Programs Affecting Safety and
Innovation in Pediatric Therapies", 22-May-2007
This hearing was held by the U.S. House of Representatives Committee on Energy and
Commerce's subcommittee on Health. In this testimony, Lori Reilly, PhRMA's Vice President
of Policy & Research, discusses the following topics: - the pediatric exclusivity program -
pediatric studies conducted over the last 10 years. - the most frequently studied ...
(Abstract truncated to see more please, go to the document!)
USA - Congressional Testimony: Statement of Peter Lurie, M.D., M.P.H. (Public
Citizen's Health Research Group) - "Programs Affecting Safety and Innovation in
Pediatric Therapies", 22-May-2007
This hearing was held by the U.S. House of Representatives Committee on Energy and
Commerce's subcommittee on Health. In this testimony, Dr. Peter Lurie, Deputy Director of
Public Citizen's Health Research Group, discusses the following topics: - how to ensure that
studies of pediatric drugs and biologics are indeed conducted - issues surrounding ...
(Abstract truncated to see more please, go to the document!)
USA - Congressional Testimony: Statement of Robert Essner (Wyeth) -
"Alzheimer's Disease: Current and Future Breakthrough Research", 15-May-2007
On May 15, 2007, the U.S. Senate Committee on Health, Education, Labor and Pensions'
subcommittee on Aging and Retirement held a hearing on the subject of breakthrough
research on Alzheimer's disease. In this testimony, Robert Essner, Wyeth's Chairman and
Chief Executive Officer, testifies on how the private sector is trying to harness science to
overcome Alzheimer's disease.
USA - Congressional Testimony: Statement of Sandra Lynn Kweder, M.D. (Food
and Drug Administration) - "Programs Affecting Safety and Innovation in Pediatric
Therapies", 22-May-2007
This hearing was held by the U.S. House of Representatives Committee on Energy and
Commerce's subcommittee on Health. In this testimony, Rear Admiral Sandra Kweder,
Deputy Director of CDER's Office of New Drugs, discusses FDA's role with respect to