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- New Year's resolutions for FDA.
- Commissioner David Kessler outlined his plans for the Food and Drug Administration FDA at the Food and Drug Law Institute. He has created a new team of officials to facilitate his goals for making the FDA a more decisive agency. The agency will also movCommissioner David Kessler outlined his plans...
- Research articles 1992-02-01
- FDA's proposed protein rule seen impacting tallow makers. (Food and Drug Administration)
- THE NEW YEAR has brought bad news for the rendering industry as Food & Drug Administration has proposed a ban on the sale of certain protein products. Calorific products like tallow would be exempt from the ban, but that end of the business is ...
- Research articles 1997-01-13
- FDA's Proposed Protein Rule Seen Impacting Tallow Makers
- THE NEW YEAR has brought bad news for the rendering industry as Food & Drug Administration has proposed a ban on the sale of certain protein products. Calorific products like tallow would be exempt from the ban, but that end of the business is st THE...
- Research articles 1997-01-13
Additional Resources
- Bristol-Myers Squibb Company F4Q08 and Full Year Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions Your first question comes from John Boris with Citigroup. John Boris - Citigroup My first question is for Elliott. Yesterday there was an early communication from the FDA on a safety review on clopidagril, most notably on patients that...
- Earnings calls 2009-01-27
- FDA, Clinical Trial Calendar Updates: AMAG Pharma, Immunomedics
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision...
- External links 2009-05-12
- FDA, Clinical Trial Calendar Updates: Thoratec, Allos Therapeutics
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision...
- External links 2009-04-21
- FDA Probes Shine Harsh Light on Pharma Biz
- It must be awful to work at the FDA right now. There you are, sitting in your cubicle, trying to make sure the pharmaceutical industry cures more people than it kills. But every five minutes some investigator from the Government Accountability Office calls you into the conference room for a...
- Blog posts 2008-07-31
- FDA Doing A Great Job - Says FDA
- Despite growing criticism of the agency, the Food and Drug Administration says things are just getting better and better. Its headline for today's press release about its own Food Protection Plan: "FDA Reports Significant Progress in Protecting the Food Supply." This is a much cheerier outlook than...
- Blog posts 2008-12-01
- FDA Calendar Update: Cell Therapeutics
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 285 entries as of 7/29/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA....
- External links 2009-07-29
- FDA promotes new drug-making technologies
- Recognizing that some drug companies have introduced new manufacturing technologies in their facilities in Germany and Australia but not in the United States, presumably because of concerns about the regulatory environment, the FDA has decided to assume the leadership role in facilitating the introduction of process analytical technology PAT here....
- Research articles 2002-05-01
- Food Policy Roundup: Ron Kirk, Mexico Tariffs, FDA Divorce, and More
- New trade rep was food company board member -- Former Dallas mayor Ron Kirk was sworn in Friday as the U.S. trade representative, the top post for negotiating and enforcing trade agreements. Kirk was on the board of directors of Dean Foods, PetSmart, and restaurant chain company Brinker International,...
- Blog posts 2009-03-23
- Food Roundup: Coke to Launch Stevia Drinks While Pepsi Waits, FDA and EPA Disagree on Mercury, and More
- Coke to launch stevia drinks -- Coca-Cola will start selling drinks containing stevia in the U.S., even though the FDA has not yet declared that the new zero-calorie sweetener is safe. PepsiCo said it will wait for official approval before marketing its own stevia products. [Source: AP] ...
- Blog posts 2008-12-15
- Food Imports and Listeria Are Among FDA's 1999 Priorities
- With the start of a new year, FDA's Center for Food Safety and Applied Nutrition CFSAN announced its food safety priorities for 1999 include stepping up surveillance of imported fruits and vegetables, investigating the risk of listeria, and swiftly approving additives that can safeguard the nation's food supply, FDA said.
- Research articles 1999-02-01
- With New CV Drugs, Gilead Tests Its Commitment to Efficiency
- Gilead received some good news today with the results of a positive phase 3 study of its new high-blood pressure drug, darusentan. Combined with Gilead's purchase of CV Therapeutics to gain the chronic angina drug Ranexa, this marks a new push into the cardio-vascular area for a...
- Blog posts 2009-04-03
- Heart attack drug receives FDA clearance; new clot buster will provide help for heart attack sufferers
- GAITHERSBURG, Md.--HealthWire--Oct. 30, 1996--Boehringer Mannheim Corporation, Therapeutics Division announced it has received clearance from the U.S. Food and Drug Administration FDA to market RetavaseTM reteplase, a new thrombolytic agent to help treat the 1.5 million American patients suffering from heart attack each year.
- Research articles 1996-10-30
- Ligand Updates Naveglitazar Development Plan Following Positive Phase II Data Presentation at ADA and New FDA Divisional Guidance for PPAR Drug Development
- SAN DIEGO -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) commented on the positive Phase II data on naveglitazar (LY818) presented at the annual meeting of the American Diabetes Association ADA, and noted the new FDA Divisional guidance for the PPAR class of compounds. The new guidance will delay initiation of all...
- Research articles 2004-07-08
- Can Spectrum Pharmaceuticals Benefit from FDA Action on Zevalin?
- Michael Becker submits: According to the American Cancer Society [ACS], non-Hodgkin lymphoma [also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma] is a cancer that starts in cells of the lymph system, which is part of the body’s immune system. NHL is the fifth most common cancer in...
- External links 2009-07-01
- Is GSK's Top R&D Deal Linked to Its "Undisclosed" FDA Application?
- GlaxoSmithKline was involved in three of the five biggest R&D collaborations of 2008, indicating that CEO Andrew Witty's plan to outsource GSK's R&D functions is well under way. The stats were assembled by Gen News, an R&D publication. (BNET readers are already familiar with the theory that...
- Blog posts 2009-01-01
- Is GSK's Top R&D Deal Linked to Its "Undisclosed" FDA Application?
- GlaxoSmithKline was involved in three of the five biggest R&D collaborations of 2008, indicating that CEO Andrew Witty's plan to outsource GSK's R&D functions is well under way. The stats were assembled by Gen News, an R&D publication. (BNET readers are already familiar with the theory that internal R&D at...
- News items 2009-08-07
- VisiJet, Inc. Reports Third Quarter 2004 Results; VisiJet launches FDA and CE approved EpiLift System in worldwide marketing and sales campaign
- IRVINE, Calif. -- VisiJet, Inc. (Nasdaq; VJET) reported revenues for the third quarter ended September 30, 2004 of $982,567 compared to nil reported in the same quarter of last year. The increase in revenue is attributed to the sales of the company's new EpiLift System in international markets. The company...
- Research articles 2004-11-17
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