FDA Lays Out Rules for OTC Liquid Meds
The FDA’s new guidance for companies that make over-the-counter liquid medications — such as cough syrups and cold remedies — calls for packaging with calibrated dosing devices to prevent accidental overdose. Most liquid medicines already come with a dosing device, such as a cup or a dropper, but the FDA would like every liquid drug […]
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Ranbaxy, FDA in settlement talks over $1 billion fine: Report
Ranbaxy Laboratories and the US health regulator are reportedly negotiating a settlement to lift a ban on the sale of the drugs produced at two of the company’s plants in India, which could involve payments and fines exceeding $1 billion. A magazine report, quoting unnamed sources, said the US Food and Drug Administration (USFDA) and […]
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The war over Lipitor – Ranbaxy Quality Problems Lead to Market Chaos
Just after Thanksgiving this year, if all goes as planned, the pharmaceutical industry will pass a historic milestone: A generic version of Lipitor — the biggest-selling prescription drug on the face of the earth — will go on sale for the first time in the U.S. You’d think that in this era of generic-drug dominance, […]
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Many new drugs did not have comparative effectiveness information available at time of FDA approval
Only about half of new drugs approved in the last decade had comparative effectiveness data available at the time of their approval by the U.S. Food and Drug Administration, and approximately two-thirds of new drugs had this information available when alternative treatment options existed, according to a study in the May 4 issue of JAMA. […]
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FDA cracks down on sale of bogus STD cures
Companies selling drugs that falsely claim to prevent, treat or protect against sexually transmitted diseases are the target of a government crackdown announced today. In a joint effort, the U.S. Food and Drug Administration and the Federal Trade Commission said they had ordered 11 companies — including one from Windermere — to stop the sale […]
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Domestic bulk drug industry to benefit from drug patent expiries in regulated markets: ICRA
The API (Active Pharmaceutical Ingredient or bulk drug) outsourcing trend within the global pharmaceutical industry remains intact as pharmaceutical companies are increasingly looking to maintain focus on core competencies, access new technologies, preserve capital and ensure multiple sources of raw material supply. However, API suppliers in Europe and US are facing increasing pricing pressures due […]
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Teva resumes production at Irvine, CA facility
Teva has resumed production at its Irvine, California plant a year after quality control issues put production on hold. A 2009 US Food and Drug Administration (FDA) warning letter led to Teva voluntarily putting production on hold in April 2010. Fixing the problems took longer than Teva first expected but in February the company predicted […]
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Shortages of key drugs endanger patients
Doctors, hospitals and federal regulators are struggling to cope with an unprecedented surge in drug shortages in the United States that is endangering cancer patients, heart attack victims, accident survivors and a host of other ill people. A record 211 medications became scarce in 2010 — triple the number in 2006 — and at least […]
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Investors mobilize in fight to shake up the FDA
In the 1990s, the Food and Drug Administration felt the heat when AIDS activists marched in the streets, shouting about how bureaucratic foot-dragging meant that patients died while waiting for new drugs. The FDA listened. It started completing safety and effectiveness reviews faster. May 19 – Webinar – Former FDA Chief Council Sheldon Bradshaw – […]
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US FDA looks to improve design and cleaning instructions for reusable medical devices
The US Food and Drug Administration announced steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to the transmission of disease. Medical devices intended for repeated use are commonplace in health care settings. They are typically made of durable substances that can withstand reprocessing, a multi-step process which includes […]
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