Articles by Jill Wechsler - BioPharm International



Articles by Jill Wechsler

Biotech Manufacturers Face a Challenging 2008

FDA and industry must contend with new safety policies, pricing concerns, and pressure to innovate
Jan 1, 2008

The new year begins on a note of optimism. A major breakthrough in stem cell research promises to open the door to new biomedical research opportunities. The drawn-out Congressional debate over user-fee reauthorization and drug safety regulation is over, and most parties seem satisfied with resulting compromises. The vaccine industry is experiencing a resurgence after years in the doldrums, with important new vaccines on the market and more under development. And unlike many previous years, the US Food and Drug Administration (FDA) had a confirmed commissioner for all of 2007 and relatively stable leadership.

Personalized Medicine May Rationalize the Coverage of Specialty Therapies

Medicines targeted to select patients can justify premium prices, reduce drug safety problems, and improve care
Dec 1, 2007

The personalized medicine bandwagon is on a roll, offering a new model for calculating reimbursement of high-cost biotech therapies. Strategies for identifying patients who will respond to a certain therapy, as well as those most likely to suffer adverse events, promise to improve healthcare quality while eliminating waste and inappropriate spending. Interventions based on individual genetic characteristics may have limited sales, but support higher prices and less costly clinical research methods.

FDAAA Boosts Fees, Broadens Disclosure

Congress postpones debate on follow-on biologics while adopting new policies likely to reshape drug development
Nov 1, 2007

Congress postpones debate on follow-on biologics while adopting new policies likely to reshape drug development

FDA Modernizes Biotech Regulation Over The Past 20 Years

From a small laboratory to a highly specialized organization, the FDA has grown with the changing needs of the biotech field
Oct 1, 2007

Federal regulation of biologics began more than 100 years ago with the enactment of the Biologics Control Act of 1902. That act required licensing of establishments to manufacture and sell vaccines, sera, antitoxins, and other similar products in order to prevent deaths from contaminated vaccines, as had recently occurred with the diphtheria antitoxin.

FDA Leglislation Tackles Safety Issues

Biotech manufacturers face higher user fees plus more testing and data disclosure to prevent unsafe drug use
Sep 1, 2007

The new legislation authorizes the use of fee revenues for drug safety oversight and assessment throughout a product's lifecycle.

Biotech Manufacturers Face Competition from "Similar" Follow-Ons

New legislation offers extended data exclusivity to innovators in exchange for a flexible approval process
Aug 1, 2007

The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms.

Manufacturers Tackle Neglected Diseases

Innovative technology can help develop treatments and vaccines for third world populations and national defense
Jul 1, 2007

Now equipment makers are designing new systems that can be deployed rapidly, are less costly to build, and require less water and power to operate.

FDA Moves to Streamline GMP Inspections

Fewer field offices and inspectors will increase reliance on manufacturers to ensure product and process quality
Jun 1, 2007

FDA's approach involves adopting efficient strategies for targeting inspections to more high-risk operations likely to have the greatest impact on public health.

Senate FDARA Approval Moves PDUFA to the House

May 23, 2007

Following the US Senate approval of the FDA Revitalization Act (FDARA, S.1082) in May, the debate over drug safety and the reauthorization of the Prescription Drug User Fee Act (PDUFA) now moves to the House.



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