 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
Survey Gives Tips for Devicemakers to Reduce Battery ProblemsHealthcare providers experience the most frequent battery problems with large-volume infusion pumps and would like manufacturers to add green, yellow and red LED lights that change color when the battery status changes. Read More
Strong Compliance Program Hinges on CEO CommitmentStrong buy-in at the top is essential to developing and maintaining a successful compliance program, experts told attendees at the Medical Device Manufacturers Association meeting last month. 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petition requesting the agency acknowledge that its noncrush-resistant version of its opioid painkiller Opana ER was withdrawn from the market for safety reasons, a move that would have blocked generic versions of the drug.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
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Survey Gives Tips for Devicemakers to Reduce Battery ProblemsHealthcare providers experience the most frequent battery problems with large-volume infusion pumps and would like manufacturers to add green, yellow and red LED lights that change color when the battery status changes. Read More
Strong Compliance Program Hinges on CEO CommitmentStrong buy-in at the top is essential to developing and maintaining a successful compliance program, experts told attendees at the Medical Device Manufacturers Association meeting last month. Read More
$20M Goldman Sachs Investment Highlights Indian Medtech GrowthGoldman Sachs last week announced plans to invest about $20 million in Indian devicemaker BPL Medical Technologies, marking one of the largest medtech investments made to date in an emerging market. Read More
U.S. FDA Losing Global Ops Chief AutorDeborah Autor, U.S. Food and Drug Administration deputy commissioner for global regulatory operations and policy, is leaving to join the regulatory policy team at generic drugmaker Mylan. Read More
Report Points to Steep Four-Year Rise in Device Warning LettersThe FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds. Read More
Anvisa Harmonizes Device, IVD GMPsBrazil is streamlining its good manufacturing practice requirements, replacing RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostics with a single regulation, RDC 16/2013. 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
Tenth Annual Medical Device Quality Congress
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