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The FDA said Thursday that all manufacturers have voluntarily complied with an agency ban on selling acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet. Read More
The FDA is continuing its push to find ways to curtail opioid abuse, calling for suggestions and recommendations on innovative packaging, storage and disposal systems, technologies or designs that would thwart abusers. Read More
The FDA wants manufacturers of low molecular weight heparin (LMWH) products to do a better job of assessing immunogenicity risk before submitting their products for approval. Read More
GlaxoSmithKline alerted consumers that five lots of its OTC weight loss drug Alli may have been tampered with after fielding complaints that a different drug was in some of the bottles. Read More
New authorities granted to the FDA in 2012 that stiffened penalties for drug counterfeiters are failing to curb the problem of fake drugs because they do not apply to distributors of counterfeits. Read More
Two new challenges emerged last week to the controversial drug Zohydro ER, as Vermont became the second state to slap restrictions on the drug and U.S. Attorney General Eric Holder announced he would look into the way the FDA approved the product. Read More
With the FDA facing charges of indifference to the problem of opioid abuse, the agency Thursday recast itself as proactive on the issue, announcing approval of a consumer-friendly new injector that treats opioid overdose. Read More
With its controversial painkiller Zohydro already banned in Massachusetts and federal lawmakers looking to follow suit, Zogenix has initiated a fierce lobbying campaign to save its flagship product. Read More
Republican lawmakers Tuesday blasted CDER Director Janet Woodcock for the FDA’s consulting with trial attorneys and not brand or generic drugmakers when developing a controversial proposed overhaul of generic drug labeling rules. Read More
Advocates for minorities and other patient groups that are underrepresented in clinical trials want the FDA to create incentives for drugmakers that include those groups in studies and become more aggressive in delaying drugs that don’t include them. Read More