 New Bill May Spur Separate Swift Approval Process for Chronic Illness Meds: AidesA new bill intended to spur drugmaker interest in developing drugs for chronic illnesses may prompt creation of a distinct approval process for such treatments, congressional aides say. Read More
Lawmakers Probe Drugmakers on Generic ADD Drug ShortagesSeveral Democratic lawmakers are requesting information from two brand drugmakers and the Drug Enforcement Administration (DEA) on production quotas that may limit generic attention deficit disorder (ADD) drugs. Read More
Contraceptive Sales Could Rise With No-Copay Final RuleContraceptive sales could climb this summer as an HHS final rule requires most health insurance plans to cover preventive services for women, without charging co-pays, beginning Aug. 12. Read More
Quick PDUFA Passage Threatened by Delayed Medical Device User Fee AgreementDrugmakers and industry trade groups are calling for speedy passage of the Prescription Drug User Fee Act (PDUFA) with few amendments outside the agreed-upon goals letter. Read More
Watson, Amphastar Score Lovenox Victory; At-Risk Launch PossibleA federal appeals court has lifted an injunction that barred Watson Pharmaceuticals and Amphastar from selling a generic version of Sanofi’s blockbuster blood-thinner Lovenox — a decision that has yet to be finalized but that has emboldened the partners to launch the generic “immediately.” Read More
Elan, Biogen Add Third PML Risk Factor to Tysabri LabelBiogen Idec and Elan are changing the U.S. label for multiple sclerosis (MS) drug Tysabri to add anti-JC Virus (JCV) antibody presence as a risk factor for developing a rare brain infection. Read More
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Lawmakers Lambaste Drugmakers for ‘Egregious’ PricesLawmakers outraged by what they call extraordinary drug price increases have asked the Government Accountability Office to see if the increases are justified and directed the Federal Trade Commission (FTC) to investigate a drug firm’s potential anti-competitive conduct for one product. Read More
CBER Guidance Addresses Trial Design for IGIV ProductsA statistical demonstration of a serious infection rate of less than 1 per person-year is adequate to provide substantial evidence of efficacy in clinical trials of investigational human immune globulin intravenous (IGIV) products, CBER says. Read More
FDA Launches Fellowship ProgramIn an effort to attract more scientific talent to the FDA, the agency is launching a two-year fellowship program designed to train scientists and engineers on the scientific foundations of its regulatory actions. Read More
DME Firm Owner Flees Country Following Fraud ConvictionThe owner of two south Florida durable medical equipment (DME) companies has fled the country after receiving a 130-month prison sentence for defrauding Medicare. Read More
St. Jude Gets FDA Approval of Wireless TransmitterThe FDA has approved St. Jude Medical's Merlin@home transmitter, a radio-frequency wireless technology that remotely monitors patients' implanted cardiac devices. Read More
SyntheMed Gets Canadian Approval for Adhesion TreatmentSyntheMed received Health Canada approval for the use of Repel-CV to reduce adhesions in pediatric patients who undergo open-heart surgery. Read More
Lawmakers Probe Drugmakers on Generic ADD Drug ShortagesSeveral Democratic lawmakers are requesting information from two brand drugmakers and the Drug Enforcement Administration (DEA) on production quotas that may limit generic attention deficit disorder (ADD) drugs. Read More
Contraceptive Sales Could Rise With No-Copay Final RuleContraceptive sales could climb this summer as an HHS final rule requires most health insurance plans to cover preventive services for women, without charging co-pays, beginning Aug. 12. Read More
Quick PDUFA Passage Threatened by Delayed Medical Device User Fee AgreementDrugmakers and industry trade groups are calling for speedy passage of the Prescription Drug User Fee Act (PDUFA) with few amendments outside the agreed-upon goals letter. Read More
Watson, Amphastar Score Lovenox Victory; At-Risk Launch PossibleA federal appeals court has lifted an injunction that barred Watson Pharmaceuticals and Amphastar from selling a generic version of Sanofi’s blockbuster blood-thinner Lovenox — a decision that has yet to be finalized but that has emboldened the partners to launch the generic “immediately.” Read More
Elan, Biogen Add Third PML Risk Factor to Tysabri LabelBiogen Idec and Elan are changing the U.S. label for multiple sclerosis (MS) drug Tysabri to add anti-JC Virus (JCV) antibody presence as a risk factor for developing a rare brain infection. Read More
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