 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
J&J Looks to Emerging Markets Amid Soft U.S. SalesJohnson & Johnson (J&J) is looking to emerging markets and diabetes care to propel future sales of devices and diagnostics, company executives said in a Jan. 24 earnings call. Read More
EC Seeks More Data on PIP Implants, Plans to Ramp up Device VigilanceDevicemakers across the EU should brace themselves for increased surveillance by competent authorities, including unannounced inspections, additional testing of products already on the market and heightened controls of notified bodies, the European Commission said following receipt of a “rapid scientific opinion” on the safety of faulty silicone breast implants. 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
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J&J Looks to Emerging Markets Amid Soft U.S. SalesJohnson & Johnson (J&J) is looking to emerging markets and diabetes care to propel future sales of devices and diagnostics, company executives said in a Jan. 24 earnings call. Read More
EC Seeks More Data on PIP Implants, Plans to Ramp up Device VigilanceDevicemakers across the EU should brace themselves for increased surveillance by competent authorities, including unannounced inspections, additional testing of products already on the market and heightened controls of notified bodies, the European Commission said following receipt of a “rapid scientific opinion” on the safety of faulty silicone breast implants. Read More
U.S., EU Devicemakers Promote Ethical Ties With DistributorsU.S. and European devicemakers should establish compliance programs integrating individual risk analyses with local laws to ensure ethical interactions with third-party distributors, an AdvaMed-Eucomed joint guidance states. Read More
FDA Offers Guidance on Humanitarian Use Device RequestsThe U.S. Food and Drug Administration (FDA) is asking for comments on new draft guidance on humanitarian use device (HUD) designations. Read More
First Test Approved for Brain Infection Linked to Multiple Sclerosis DrugThe first blood test that can measure multiple sclerosis (MS) patients’ risk for a rare but serious brain infection got FDA clearance Jan. 20. Quest Diagnostics’ Stratify JCV antibody test is the first blood test for qualitative detection of polyomavirus John Cunningham virus (JCV) antibodies. Read More
Industry Disappointed by TGA’s Weak Stand on Ethical CodesAustralian devicemakers are criticizing a Therapeutic Goods Administration (TGA) report on regulatory reform that fails to endorse a common industry conduct code. 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
FDA Compliance Boot Camp 2012
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