 Woodcock Pushes Multi-Stakeholder, Biomarker-Based Clinical Trial ParadigmDrugmakers need to shift from phased, single-drug clinical trials toward a new paradigm of collaborative assessments of multiple drugs based on biomarkers, CDER Director Janet Woodcock said Tuesday, using the ongoing breast cancer trial I-Spy 2 as an illustrative example. Read More
Hydrocodone Decision Delay Reflects Industry TensionsCongressional carping that the FDA is taking too long to decide if hydrocodone combination products should be further restricted is well-intentioned but dismisses the fine line between enforcement and ensuring pain medications are available to those who need them, experts say. Read More
FDA Rejects Endo’s Petition to Deny Generics of Opana ERThe FDA May 10 denied Endo Pharmaceuticals’ citizen petition requesting the agency acknowledge that its noncrush-resistant version of its opioid painkiller Opana ER was withdrawn from the market for safety reasons, a move that would have blocked generic versions of the drug. Read More
FDA to Hold Two-Day Public Meeting on REMS ChallengesThe FDA plans to hold a two-day public meeting in July on the challenges of standardizing and assessing risk evaluation and mitigation strategies (REMS) for drug and biological products — part of a commitment the agency made to drugmakers under the most recent user-fee agreement. Read More
Biosimilar Interchangeability Battle Moves to CaliforniaAll eyes will be on California this week as it joins a growing list of states trying to decide how to regulate the substitution of biosimilar drugs for their more costly brand counterparts. Read More
House Committee Investigates FDA Official’s Sudden DepartureGOP House leaders are investigating the brief tenure of Leona Brenner-Gati in the wake of the former FDA acting deputy commissioner’s sudden departure earlier this month. 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
Hydrocodone Decision Delay Reflects Industry TensionsCongressional carping that the FDA is taking too long to decide if hydrocodone combination products should be further restricted is well-intentioned but dismisses the fine line between enforcement and ensuring pain medications are available to those who need them, experts say. Read More
FDA Rejects Endo’s Petition to Deny Generics of Opana ERThe FDA May 10 denied Endo Pharmaceuticals’ citizen petition requesting the agency acknowledge that its noncrush-resistant version of its opioid painkiller Opana ER was withdrawn from the market for safety reasons, a move that would have blocked generic versions of the drug. Read More
FDA to Hold Two-Day Public Meeting on REMS ChallengesThe FDA plans to hold a two-day public meeting in July on the challenges of standardizing and assessing risk evaluation and mitigation strategies (REMS) for drug and biological products — part of a commitment the agency made to drugmakers under the most recent user-fee agreement. Read More
Biosimilar Interchangeability Battle Moves to CaliforniaAll eyes will be on California this week as it joins a growing list of states trying to decide how to regulate the substitution of biosimilar drugs for their more costly brand counterparts. Read More
House Committee Investigates FDA Official’s Sudden DepartureGOP House leaders are investigating the brief tenure of Leona Brenner-Gati in the wake of the former FDA acting deputy commissioner’s sudden departure earlier this month. Read More
Conducting Bulletproof CAPA Investigations — ADVANCED
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