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Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
May 02, 2007
Fewer field offices and inspectors will increase reliance on manufacturers to ensure product and process quality.
April 02, 2007
FDA is buried in postapproval manufacturing submissions and seeks to reduce the scope of changes that require agency scrutiny.
March 02, 2007
FDA's new safety program, Critical Path Initiative, and user-fee proposal seek to reinvigorate pharmaceutical R&D.
February 08, 2007
Rockville, MD (Jan. 30)-The White House proposes a record $2 billion budget for FDA for the year that starts Sept. 30, 2007, an amount that consists of $1.6 billion in appropriated funds, plus some $450 million user fees for drugs, biologics, medical devices and other products.
February 02, 2007
"Quality by design" (QbD) and "quality risk management" at long last seem to be moving from the buzzword stage to becoming important influences on drug development and manufacturing. A series of quality standards issued by the International Conference on Harmonization (ICH) is encouraging the adoption of common quality-based drug manufacturing approaches designed to reach the "desired state" of drug manufacturing (i.e., more efficient, agile, flexible operations that can reliably produce high-quality drug products with less regulatory oversight). These developments reflect increased pressure to make pharmaceutical manufacturing more efficient and less wasteful and to encourage regulators in all regions to focus on the most critical issues affecting product quality and patient safety.
January 02, 2007
Democrats are back on top in Congress and are mapping a broad agenda for change. Prescription drug pricing, medical product safety, and access to needed treatments are high on the priority list. Manufacturers will be in the hot seat answering questions about patent practices, high-risk products, and why drugs cost less in other countries than in the United States. The real challenge, however, will be to gain approval of a bill to reauthorize the Prescription Drug User Fee Act (PDUFA) before the program expires on Sept. 30, 2007. Such legislation also would renew user fees for medical devices and continue the pediatric drug exclusivity program.