Articles by Maribel Rios - Pharmaceutical Technology

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Articles by Maribel Rios

Federal Report Outlines Cost Savings in Biosimilars Approval Pathway

Jul 3, 2008

The Congressional Budget Office has released a report that provides a picture of the financial impact from the enaction of S.1695, the Biologics Price Competition and Innovation Act of 2007.

Study Tests Antibody-Coated Nanotubes and NIR Light to Kill Cancer Cells

Jun 26, 2008

Biomedical researchers at UT Southwestern Medical Center and nanotechnology scientists at UT Dallas are collaborating on a study that seeks to selectively kill cancer cells using monoclonal antibodies to coat carbon nanotubes that heat up when exposed to near-infrared (NIR) light.

FDA, EMEA Consider Seven New Toxicity Tests

Jun 19, 2008

The US Food and Drug Administration and the European Medicines Agency will collaborate in efforts that would allow drug companies to submit results of seven new drug-safety tests.

FDA, EMEA, and European Commission Set First Goals in Med Regulation

Jun 5, 2008

The transatlantic cooperation of the European Commission, the European Medicines Agency, and the US Food and Drug Administration was recognized at the Second Meeting of the Transatlantic Economic Council, held mid May in Brussels. The TEC is tasked with overseeing and accelerating government-to-government cooperation to advance economic integration between the United States and the European Union.

PDA Takes On Risks for Patients

Risk management, and its benefits for patients, plays a big role at the PDA Annual Meeting.
Jun 2, 2008

Risk management, and its benefits for patients, plays a big role at the PDA Annual Meeting.

Toxicity Study Reveals Clues into Buckyball Mechanics

May 29, 2008

University of Calgary biochemists used computer simulation in a new toxicity study to predict how "buckyballs," carbon-60 soccer ball-shaped nanomolecules, could damage animal cells.

Congress Holds FDA Preemption Hearings

May 20, 2008

The Committee on Oversight and Government Reform held a hearing on whether the US Food and Drug Administration's drug and medical device regulation bar state liability claims.

FDA Requests Updates for User-Fee Assessment

May 15, 2008

To establish user fees for the 2009 fiscal year, the US Food and Drug Administration is asking pharmaceutical manufacturers to provide a list of products and finished-dose manufacturing facilities subject to such fees by June 16, 2008.

FDA Plans Boost in Lab Capacity and Staff

May 8, 2008

To keep pace with proposed increases in the number of manufacturing inspections, the US Food and Drug Administration's Office of Regulatory Affairs (ORA) has announced it will increase laboratory capacity and staff.

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Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
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