The pharmaceutical industry is finally facing one of its worst-case scenarios: FDA's drug-safety officials will now hold considerably more sway over both experimental and approved drugs. Prodded by Congress in the wake of several major drug-safety and effectiveness concerns -- starting, perhaps, with Vioxx, and since expanded...
Coca-Cola and Cargill may finally have come up with something the food industry has been seeking for years: A "natural" zero-calorie sweetener. This week, the companies introduced "Truvia," a product made from the South American plant stevia, which has been used for decades in Paraguay and Brazil,...
By Martinne Geller NEW YORK (Reuters UK) - Agribusiness giant Cargill CARG is starting to roll out Truvia, its natural, no-calorie sweetener on Wednesday, and expects the product to be on grocery shelves across the U.S. sometime this fall. Truvia is made from certain compounds in...
For all its rhetoric about advancing human health, the drug industry has never shown much interest in tropical diseases that kill or plague millions of people, for the very simple reason that poor nations can't pay top dollar for new drugs. That may be changing, though, thanks to a new...
By Susan Heavey BELTSVILLE, Maryland (Reuters UK) - Anti-seizure drugs used to treat epilepsy carry an increased risk of suicidal thoughts and behaviour but not enough to warrant a black box warning, a U.S. advisory panel concluded on Thursday. Members of the Food and Drug Administration's...
If the processes in any pharmaceutical industry are under control and well understood, Food and Drug Administration FDA can do things very differently. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research CDER joined a panel of pharmaceutical manufacturing executives for the keynote discussion at Interphex conference in...
The Food and Drug Administration FDA faced several challenges after the President of U.S.A laid down the Management Agenda PMA as a framework for a citizen-centered, results-oriented, and market-based Federal government accomplished through five executive branch-wide initiatives. This study focuses on how the FDA Information Technology IT consolidation solution, driven...
It's been one year since the Food and Drug Administration FDA announced its aggressive two-year overhaul of current Good Manufacturing Practices cGMPs based on risk analysis. And in a September 3 press conference, FDA leaders marked the midpoint of the initiative with a flurry of announcements advancing its efforts to...
Noting a dramatic increase in counterfeiting within the U.S., and more-sophisticated packaging and distribution channels, Food and Drug Administration FDA has rolled out a new initiative designed to protect the public from counterfeit products. Pharmaceutical manufacturers also face increasing losses graph and liability from counterfeiting. The paper informs that FDA...
After years of prodding from the pharmaceutical industry, the U.S. Food and Drug Administration FDA published its final rule on 21 CFR Part 11, covering electronic documents and signatures, on March 20, 1997. FDA came up with 21 CFR Part 11 in response to industry's request for regulatory guidance on...
Phytase, an enzyme that Diversa co developed with Danish drug maker Danisco, is being produced in full-scale 90,000-L quantities at Fermic's facilities. The enzyme helps degrade phytic acid in animal feeds so that animals can absorb phosphate more readily. The paper reveals that Diversa has applied for FDA approval of...
A fast-growing biopharmaceutical company needed help. The company's new management team faced significant pressure to submit a new Biologics License Application BLA within three months. PRTM worked with the client to conduct a rapid operational readiness assessment of all quality systems, supply chain processes, and IT systems. It then created...
A leading international medical device and pharmaceutical company needed to redefine and redeploy their entire quality system in response to the results of an FDA inspection. PRTM led the overall quality system redesign and implementation effort. It created seven internal teams to address each of seven components of the quality...
Pharmaceutical plants that make prescription drugs have a greater likelihood of being inspected than those making non-prescriptions. FDA drug investigators with increased training find more acts of noncompliance at facilities they inspect. Sites that have changed ownership are more likely to have regulatory problems. If numbers don't lie, these statements...
By focusing on the pharmaceutical manufacturing process, ASTM standards for process analytical technology PAT promise to bring engineering rigor and proactive decision-making to pharmaceutical quality. Process understanding can be a foundation for innovation and continuous improvement in pharmaceutical development and manufacturing. FDA's Process Analytical Technology initiative aims to help the...
The U.S. has long laid claim to the safest, highest quality drug supply in the world. Indeed, under the aegis of the 65-year-old Food, Drug and Cosmetic Act, the pharmaceutical industry and the U.S. Food and Drug Administration have labored long and hard to build an extensive closed system of...
PAT Process Analytical Technologies is the rarest of revolutions. It needed brilliant thinkers and some prodding to get off the ground, but it is now a team-driven movement. If it succeeds, it will mean unprecedented changes for both industry and regulators. When FDA's original PAT team was assembled in 2002,...
The same drive toward automation and digital control that has transformed modern manufacturing is reshaping the pharmaceutical production world. At one level, Food and Drug Administration FDA addresses this by requiring validation of control and information systems that interact with production, the same as it does for reactors or tableting...
U.S. Food and Drug Administration FDA caught many drug makers by surprise when it announced a broad-ranging initiative to overhaul how it regulates pharmaceutical manufacturing operations. The announcement comes at a time when a significant number of major drug makers have struggled to meet the FDA's current Good Manufacturing Practices...
