 Judge Denies Matrixx’s Proposed Settlement of Zicam Class ActionsA U.S. district court judge in Arizona has declined to approve Matrixx Initiatives’ proposed settlement for a series of class action lawsuits concerning its recalled OTC cold remedy Zicam. Read More
FDA Reviewing Heart Risk Data for Parkinson’s Drug StalevoThe FDA is evaluating clinical trial data that suggest Orion Pharma and Novartis’ Parkinson’s drug Stalevo may be associated with a slightly increased risk for cardiovascular (CV) events. Read More
FDA Reveals First Generic Challenge to Celgene’s Cancer Drug RevlimidThe FDA has received an ANDA to market a generic version of Revlimid 25 mg, the first challenge to Celgene’s blockbuster cancer drug. Read More
FDA Asking Devicemakers to Help With Overseas Supply OversightThe FDA is trying to stretch its enforcement reach over foreign device suppliers, potentially through consent decrees, and is asking manufacturers to take bigger steps as well to tighten the supply chain. Read More
Devicemakers Want More Clarity on Third-Party Audit ProgramDevicemakers want more clarity on third-party audits by regulatory agencies in other countries, especially when it comes to possible enforcement actions. Read More
Sanofi Bid to Acquire Genzyme Could Become Drawn-Out ProcessSanofi-Aventis’ proposed $18.5 billion acquisition of Genzyme would help turn around that company’s dogging manufacturing issues, add global expertise and handsomely reward Genzyme shareholders, according to Sanofi CEO Chris Viehbacher. Read More
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FDA Asking Devicemakers to Help With Overseas Supply OversightThe FDA is trying to stretch its enforcement reach over foreign device suppliers, potentially through consent decrees, and is asking manufacturers to take bigger steps as well to tighten the supply chain. Read More
Devicemakers Want More Clarity on Third-Party Audit ProgramDevicemakers want more clarity on third-party audits by regulatory agencies in other countries, especially when it comes to possible enforcement actions. Read More
Director of 510(k) Office Will Retire This MonthA major player in CDRH’s 510(k) process is stepping down just as the agency begins to revamp the device clearance program. Read More
FDA Expects to Publish an RFP Soon to Begin Developing UDI DatabaseAfter years of promises, the FDA says it plans to publish, within the next few months, a request for proposals (RFP) to begin the development and building of a unique device identifier (UDI) database. Read More
J&J Quality Problems Spread to Some of Its Device UnitsJohnson & Johnson (J&J), which has come under scrutiny for quality problems with its drug units, is starting to experience similar problems with its device divisions. Read More
Lawmakers: Better 510(k) Process Key to Keeping Device Jobs in USTrying to keep devicemakers, and the jobs they provide, in the U.S., lawmakers are urging the FDA to be more transparent and predictable in its review of 510(k)s. Read More
FDA Reviewing Heart Risk Data for Parkinson’s Drug StalevoThe FDA is evaluating clinical trial data that suggest Orion Pharma and Novartis’ Parkinson’s drug Stalevo may be associated with a slightly increased risk for cardiovascular (CV) events. Read More
FDA Reveals First Generic Challenge to Celgene’s Cancer Drug RevlimidThe FDA has received an ANDA to market a generic version of Revlimid 25 mg, the first challenge to Celgene’s blockbuster cancer drug. Read More
Sanofi Bid to Acquire Genzyme Could Become Drawn-Out ProcessSanofi-Aventis’ proposed $18.5 billion acquisition of Genzyme would help turn around that company’s dogging manufacturing issues, add global expertise and handsomely reward Genzyme shareholders, according to Sanofi CEO Chris Viehbacher. Read More
Germany’s Drug Pricing Reforms Legislation Moves to ParliamentThe German government’s draft law to reform the nation’s drug-pricing system has been referred to Parliament, where it faces hearings at the end of September. Read More
CMS Should Work With FDA, Avoid Paying for Ineffective DrugsThe Centers for Medicare & Medicaid Services (CMS) paid more than $43 million through Medicare Part D for “less-than-effective” (LTE) prescription drugs that should not have been covered, according to a report from the HHS Office of Inspector General. Read More
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