 SCOTUS “Pay-for-Delay” Decision Provides Roadmap for Case-by-Case Crackdown“Pay-for-delay” deals between brand drugmakers and their generic competitors can sometimes violate antitrust law, the Supreme Court ruled Monday, issuing a tempered decision that will make it easier for legal challenges to be brought by critics of the practice. Read More
EMA Urges Consideration of Patient Populations in Phthalate, Paraben UseThe European Medicines Agency May 8 published recommendations for drugmakers on the use of phthalates and parabens, urging consideration of patient populations. Read More
Drugmakers’ Shortage Prevention Programs Coming Up Short: SurveyDrugmakers’ shortage-prevention programs aren’t catching quality deviations as designed, according to a new survey that paints a stark picture of shortage prevalence. Read More
Industry, Patient Advocates Spar Over Need for 510(k)s for ModificationsIndustry’s case against significant reforms to the FDA’s policy on when devicemakers must submit a new 510(k), made during a Thursday public meeting, drew pushback from consumer groups that argued current controls don’t ensure patient safety. Read More
China Beefs Up Controls of IVD Reagents; Buyers Should Monitor for ComplianceThe China Food and Drug Administration last month released a document outlining acceptance criteria for in vitro diagnostic reagents makers. Read More
Lilly’s Phase II Stumble Puts Merck’s BACE Inhibitor in LeadEli Lilly’s decision to halt a mid-stage trial of its beta secretase (BACE) inhibitor drug to treat Alzheimer’s disease puts Merck’s own BACE inhibitor candidate in the lead, analysts say. Read More
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Industry, Patient Advocates Spar Over Need for 510(k)s for ModificationsIndustry’s case against significant reforms to the FDA’s policy on when devicemakers must submit a new 510(k), made during a Thursday public meeting, drew pushback from consumer groups that argued current controls don’t ensure patient safety. Read More
China Beefs Up Controls of IVD Reagents; Buyers Should Monitor for ComplianceThe China Food and Drug Administration last month released a document outlining acceptance criteria for in vitro diagnostic reagents makers. Read More
FDA: Devicemakers Should Consider Hacking Risks During Device DesignPremarket submissions for internet-connected medical devices should include cybersecurity risks considered during the product design, established cybersecurity controls and a traceability matrix linking the controls to the risks they mitigate, according to a draft guidance. Read More
EU Device Regulations: Little Support for PMA; Mandatory Liability Coverage ProposedEU lawmakers seemed lukewarm, at best, on the idea of subjecting the riskiest medical devices to a U.S.-style premarket approval mechanism during a May 29 debate by members of the Committee on the Environment, Public Health and Food Safety. Read More
Industry Questions Lawmakers on Reports of PTO Fee DiversionsAdvaMed, the Medical Device Manufacturers Association and other groups are questioning lawmakers about reports that the Office of Management and Budget is diverting patent application fees to general government spending to help mitigate sequester effects. Read More
NICE Takes Over UK Medtech Adoption Program, Plans Innovation BriefingsThe UK’s National Institute for Health and Clinical Excellence on May 1 took over the National Health Systems’ technology adoption program, ensuring a “more seamless and effective route” to the adoption of novel diagnostics, surgical implants and other devices. Read More
EMA Urges Consideration of Patient Populations in Phthalate, Paraben UseThe European Medicines Agency May 8 published recommendations for drugmakers on the use of phthalates and parabens, urging consideration of patient populations. Read More
Drugmakers’ Shortage Prevention Programs Coming Up Short: SurveyDrugmakers’ shortage-prevention programs aren’t catching quality deviations as designed, according to a new survey that paints a stark picture of shortage prevalence. Read More
Lilly’s Phase II Stumble Puts Merck’s BACE Inhibitor in LeadEli Lilly’s decision to halt a mid-stage trial of its beta secretase (BACE) inhibitor drug to treat Alzheimer’s disease puts Merck’s own BACE inhibitor candidate in the lead, analysts say. Read More
China, India Fine-Tuning GMPs as API Makers Rush to Meet New EU RulesChina and India are working to help local manufacturers of active pharmaceutical ingredients satisfy the tough, new quality requirements in the EU’s Falsified Medicines Directive. Read More
FDA Invites Industry Feedback on BLA Submissions, IND ReportingThe FDA is seeking industry comment on the litany of requirements for submitting BLAs, to gauge how burdensome the requirements are and if they can be streamlined. Read More
Conducting Bulletproof CAPA Investigations — ADVANCED
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