Jill Wechsler

by Jill Wechsler Manufacturers are concerned about congressional efforts to establish a Medicare pharmacy benefit and to regulate research while FDA shifts regulation of biologics and other drugs.

by Jill Wechsler A new FDA commissioner will have to oversee agency consolidation and new initiatives to counter bioterrorism.

by Jill Wechsler Agency officials are reexamining manufacturing standards and plant inspection processes.

by Jill Wechsler

by Jill Wechsler. Pressure to enact an affordable Medicare drug benefit is driving legislation that threatens patent protections and boosts cheap imports.

PDUFA III boost manufacturer fees to cover postapproval surveillance and streamline the FDA review process

by Jill Wechsler, CBER is heralding its rich regulatory history while preparing to tackle new scientific and administrative challenges.

by Jill Wechsler Concerns about product safety and stiffer FDA regulation of manufacturers may be drying up the biotech pipeline

by Jill Wechsler Bioterrorism and common infections create challenges for manufacturers.

by Jill Wechsler, pp. 55-57, 60 The industry must ensure that manufacturing systems can produce high quality and consistent therapies, efforts that may lead to comparable "subsequent entry" products.

By Jill Wechsler, pp. 52-56. More curbs on reimbursement for expensive, cutting-edge therapies may shape R&D programs and industry growth

by Jill Wechsler Continued concerns about bioterrorism will shape legislative and regulatory initiatives affecting biotech manufactures.

by Jill Wechsler Terrorist attack may postpone health policy legislation but encourage antibioterrorism initiatives.

FDA expands electronic data submission programs to improve regulatory operations and ensure appropriate and safe drug use.