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Latest News | 9 May 2012

Two Receive Debarments for FDCA Violations

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Two doctors are on the receiving end of debarment orders issued by the US Food and Drug Administration (FDA) after the agency found both to have injected patients with an unapproved and illegally [Read More...]

Tags: Banned Botox Botulinum Debarment Debarred FDA FDCA Wrinkle
Regulatory Update | 9 May 2012

European Commission: Consultation on Stakeholder Participation In HTA Network

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The European Commission is requesting input from stakeholders, including drug and device companies, as to “how the consultation with stakeholders in the Health Technology Assessment (HTA) network’s [Read More...]

Tags: CER Directive 2011/4 European Commission Health Technology Assessment HTA Input Stakeholder
Latest News | 9 May 2012

Scathing Parliamentary Report Blasts India’s Drug Regulatory Authority

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A parliamentary report authored by India’s Standing Committee on Health and Family Welfare (SCHFW) is blasting the country’s Central Drugs Standard Control Organisation (CDSCO), India’s drug [Read More...]

Tags: Blasts CDSCO DCGI India Parliament Regulatory report
Latest News | 9 May 2012

House Subcommittee Passes User Fee Reauthorization Legislation

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The US House Energy and Commerce Subcommittee on Health completed its markup process for a package of user fee programs including the Prescription Drug User Fee Act (PDUFA), the Medical Device User [Read More...]

Tags: Bill BIPUF BsUFA BUFA FDASIA GDUFA House Legislation MDUFA PDUFA User Fees
Latest News | 9 May 2012

EMA Releases New Reflection Paper for Labs Performing Clinical Trial Sample Analysis

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The European Medicines Agency (EMA) announced it has released a new reflection paper to guidance laboratories that evaluate clinical trial samples, which it hopes will establish informal guidelines [Read More...]

Tags: Analysis Clinical Studies Clinical Trials EMA Evaluation GLPs Reflection Paper Samples
Latest News | 9 May 2012

FDA Issues New Draft Guidance on Pediatric X-Ray Imaging

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The US Food and Drug Administration (FDA) announced it is releasing new draft guidance for industry on what information needs to be contained with a company’s premarket notification for any x-ray [Read More...]

Tags: CDRH Draft Guidance FDA Medical Device Meeting Pediatric Warning X-Ray
Latest News | 9 May 2012

Study: Most Drugs Lacking Information on Adequate Pediatric Use

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A study conducted by researchers at the US Food and Drug Administration (FDA) finds fewer than half of all pharmaceutical products on the market do not contain any information for how the drug should [Read More...]

Tags: Children drug ePDR JAMA Kids PDR Pediatric Pharmaceutical report Study Testing
Latest News | 8 May 2012

FDA Moves to Standardize Labeling of Drugs Imported to Ease Shortages

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The US Food and Drug Administration (FDA) appears to be institutionalizing one of the methods it uses to combat drug shortages, creating a new category for pharmaceutical products imported into the [Read More...]

Tags: drug Drug Shortages FDA Pharmaceutical Shortage
Latest News | 8 May 2012

Suspects Nabbed in Record-Setting Pharmaceutical Heist

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A pharmaceutical robbery in 2010 had all the trappings of a Hollywood-inspired heist: thieves breaking into a secure facility, tens of millions of dollars in stolen product and a cold trail. Now, that [Read More...]

Tags: Cymbalta drug Eli Lilly GSK Heist Pharmaceutical Prozac Robberies Robbery Thieves Villa Zyprexa
Latest News | 8 May 2012

House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations

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An investigation by the US House Energy and Commerce Committee that began in January 2012 continues to escalate, with members of the committee directly targeting pharmaceutical companies in an attempt [Read More...]

Tags: Abbott Amgen AstraZeneca E&C Energy and Commerce Committee House Information Merck Negotiating Negotiation Obama Pfizer PhRMA PPACA
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