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fda

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fda to New Drugs: It's Hammer Time: Wonder no further whether the recent litany of drug-safety problems would make the Food and Drug Administration more cautious about approving new drugs. In just the past four days, the agency has thrown some serious sand into the industry's drug-development works, delaying or derailing three separate programs of widely varying...; Tags: FDA, Agency, Merck & Co. Inc., Cordaptive, Federal Government, Government, David P. Hamilton; Blog posts 2008-04-29
The Week That Was in Pharma: Welcome back from the weekend. Here's a quick roundup of stories you may have overlooked over the past week: Merck said it would cut 1,200 jobs following the FDA's rejection of one cholesterol drug and a scandal that's cuts sales of its combination drug Vytorin, which it...; Tags: FDA, Drug, Observers, Federal Government, Government, David P. Hamilton; Blog posts 2008-05-12
Glaxo Wins U.S. fda Approval For Wider Advair Use: By Susan Heavey WASHINGTON (Reuters UK) - U.S. health regulators have said GlaxoSmithKline Plc's GSKGSK Advair is safe and effective to more widely treat patients with chronic obstructive pulmonary disease COPD, the drugmaker said on Wednesday. Glaxo's approval comes the same day as rival AstraZeneca...; Tags: AstraZeneca Plc., FDA, Patient, Glaxo, Advair, Federal Government, Government, GlaxoSmithKline Plc.; News items 2008-04-30
fda Loosens Rules for Overseas Drug Trials: Merrill Goozner, a former Chicago Tribune reporter turned public-health advocate he heads up the Integrity in Science Project at the Center for Science in the Public Interest, notes an interesting and almost wholly overlooked Food and Drug Administration decision that may have the effect of subjecting clinical-trial volunteers in poor...; Tags: FDA, Drug, Gist, Federal Government, Government, David P. Hamilton; Blog posts 2008-05-08
Glaxo Gets an fda Warning... With Teeth: Well before Vytorin became a cause célèbre -- which is to say, about a year ago -- GlaxoSmithKline's Avandia was the drug getting slapped around by critics for, in that case, possible heart problems that had possibly been downplayed or ignored. That case, which led to new warnings on the...; Tags: FDA, Agency, Drug Company, Glaxo, Avandia, Federal Government, Government, David P. Hamilton; Blog posts 2008-04-12

Glaxo Wins fda Approval For Wider Advair Use: WASHINGTON (Reuters) - U.S. health regulators have said GlaxoSmithKline Plc's GSKGSK Advair is safe and effective to more widely treat patients with chronic obstructive pulmonary disease COPD, the drugmaker said on Wednesday. Glaxo's approval comes the same day as rival AstraZeneca...; Tags: HEALTHCARE, GlaxoSmithKline Plc., patient, clinical trial, Pfizer Inc., London, Thomson Reuters Corp., health care, sales; News items 2008-04-30
Astra Takes on Glaxo in U.S. COPD Drug Market: By Ben Hirschler LONDON (Reuters UK) - AstraZeneca is seeking U.S. approval to sell its asthma drug Symbicort for chronic obstructive pulmonary disease COPD, ramping up competition with GlaxoSmithKline's Advair. Both are inhaled drugs combining a corticosteroid and a long-acting beta-agonist. AstraZeneca said on Wednesday...; Tags: AstraZeneca Plc., FDA, Astra, Symbicort, Federal Government, Government, Oukbs; News items 2008-04-30
Drugmakers Need to Rein in Ads, Hearing Told: By Susan Heavey WASHINGTON (Reuters) - Pharmaceutical companies need to be more responsible in touting products to consumers or else face tighter controls from Congress, a top U.S. Democratic lawmaker said on Thursday. Rep. Bart Stupak, at a hearing to discuss specific ads...; Tags: Schering-Plough Corp., Merck & Co. Inc., Pfizer Inc., pharmaceutical company, drug company, advertisement, physician, patient, U.S. Congress, Washington, risk, TV, benefit, Thomson Reuters Corp., food, technique, knowledge, marketing, sales; News items 2008-05-08
Why Biogenerics Will Survive Genzyme's Problems: The Food and Drug Administration rejected Genzyme's request to sell a version of its drug Myozyme made in a new factory, a decision some journalists and bloggers insist on casting as a black mark against the very notion of generic biotech drugs. There's just one problem: These...; Tags: FDA, Genzyme Corp., Clinical Trial, Biotech Drug, WSJ Health Blog, Biotech Industry, Biotechnology, Federal Government, Government, David P. Hamilton; Blog posts 2008-04-22
Cholesterol-drug Rejection Rips New Gash in Merck: By Ransdell Pierson NEW YORK (Reuters) - Confidence in Merck & Co's MRK earnings prospects withered on Tuesday, along with its stock price, after U.S. regulators surprisingly rejected the drugmaker's treatment to raise levels of "good" HDL cholesterol. Shares of Merck,...; Tags: Financial accounting, Merck & Co. Inc., vaccine, earnings, analyst, cost control, DJIA, Thomson Reuters Corp., New York, U.S., sales, CEO, manufacturing, strategy; News items 2008-04-29
Case Study: Enterprise Architecture in Action: 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...; Tags: Federal government, Strategy, White House, FDA, enterprise architecture, agency, benefit, information technology; Case studies
Risk-Based cGMPs: A Progress Report: 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...; Tags: Federal government, FDA, risk analysis, manufacturing, leader; White papers
PAT Brings Laboratory Analysis Online: Among the U.S. Food and Drug Administration's FDA latest admonishments to the pharmaceutical manufacturing community is for the increased use of Process Analytical Technology PAT. Broadly defined, PAT encompasses a variety of tools, technologies and methodologies designed to shift the industry's quality focus from post-production inspection to building quality into...; Tags: Federal government, FDA, pharmaceutical company, manufacturing, risk analysis, tool, industry; White papers
fda, Industry Redouble Efforts to Foil Drug Counterfeiters: 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...; Tags: Federal government, FDA, manufacturer, physician, homeland security, best practice, U.S., patient, strategy, industry; White papers
fda Grants VELCADE (Bortezomib) for Injection Fast Track Status for Relapsed and Refractory Mantle Cell Lymphoma: In this article Millennium Pharmaceuticals, Inc. informs that the Food and Drug Administration FDA has granted VELCADE fast track designation for relapsed and refractory mantle cell lymphoma, an aggressive form of non-Hodgkin's lymphoma NHL which accounts for approximately six percent of all lymphomas. Currently, VELCADE is being evaluated as a...; Tags: Federal government, VELCADE, Millennium Pharmaceuticals Inc., FDA, cell, R&D, agent, collaboration; White papers
fda May Lead Industry to Water, But Will It Drink?: 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...; Tags: Federal government, FDA, pharmaceutical company, conference, beverage, industry, manufacturing; White papers
fda Compliance and Product Commercialization for a Biopharmaceutical Company: 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...; Tags: PRTM, commercialization, supply chain, compliance, information technology; Case studies
Comprehensive Product Quality System to Achieve fda Compliance: 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...; Tags: Federal government, PRTM, FDA, medical device, compliance, team; Case studies
Can 13 Years of fda Data Teach Us Anything?: 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...; Tags: Federal government, FDA, training, analysis; White papers
The Desired State: PAT and the Road to Enlightenment: 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...; Tags: pharmaceutical company, continuous improvement, manufacturing, decision-making, performance; White papers