Opinion & analysis | Page 20 of 20 | Report Store

New Age Thinking: US FDA’s Temple Sees Third Era Of Drug Development

Robert Temple, the FDA’s voice of institutional memory, believes drug regulation has quietly entered a third era: the “Age of Individualization.” Unlike the prior eras of safety and efficacy, there is no milestone legislation to set the ground rules. But, Temple stressed, there have been significant changes in areas like the assessment of drug-drug interactions, metabolic response to therapeutics, and in the FDA’s willingness for sub-population analyses. Is there a change in the air that will result in further change in drug development as it relates to the Age of the Individual?

August 2, 2019

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FDA’s Proposed Sunscreen Rule Could Bring SPFs Back Down To Earth, Deter SPF Fraud Suits

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FDA’s proposed SPF rule would cap sunscreen claims at SPF 60+ and establish new broad-spectrum requirements for most sunscreen products, among a host of other changes. Find out how these changes could create a more even playing field among OTC sunscreen marketers and help to deter lawsuits alleging SPF fraud. Gain insights into stakeholder and environmental group perspectives.

February 19, 2019

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Six Key New Commission Documents Relating To EU Directives And New Regulations

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To help companies respond and adapt the processes they may have in place as rapid EU regulatory activity continues, Medtech Insight summarizes the six documents that have recently appeared on the European Commission’s medtech website.

September 2, 2019

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US FDA’s Temple on Real-world Evidence: “I Find the Whole Thing Very Frustrating”

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At the October FDA panel discussion at the Biopharma Congress, CDER deputy director for clinical science reiterated his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims. Pink Sheet looks deeper at his words.

September 2, 2019

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FDA Plans Consumer Survey To Better Understand Cosmetics Allergy Prevalence

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An FDA 2019 online survey is aimed at collecting data from 1,000 targeted respondents regarding their experiences with allergens in cosmetics. This survey marks the US FDA’s first efforts in four decades to document the possible link between an overall rise in allergies and the cosmetics industry.

November 7, 2018

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Device Sector Braces For Investigative Stories Critical Of Industry

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Rumblings of a series of reports and broadcasts from the International Consortium of Investigative Journalists (ICIJ) have gotten louder in the past few months, as the industry braces itself for the release of these sprawling investigations, believed to be highly critical of the medical devices industry.

November 21, 2018

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The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While ‘Wrath’- Behrendt Fumes

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In the wake of scathing investigative reports from over 250 journalists from the International Consortium of Investigative Journalists (ICIJ) regarding the safety and oversight of implanted medical devices, this article examines the situation from a uniquely EU perspective.

November 26, 2018

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2021 J.P. Morgan Healthcare Conference Review

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The 39th annual J.P. Morgan Healthcare Conference (JPM) was held virtually from January 11-14, 2021. A list of events and catalysts that were announced or updated at the conference are included in this report. Below are some key points from company presentations.

January 25, 2021

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116th Congress Could Test Cosmetic Industry’s Commitment To Reg Reform, Preemption Viability

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With Democrats taking control of the US House of Representatives in the fall of 2018, the future of proposed legislation to update cosmetics industry regulations is hazy, but likely to result in stricter regulations for products sold in the United States.

November 19, 2018

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Interventional Neurology: Cerebral Aneurysm and Arteriovenous Malformation Systems

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This medical market and technology report provides a comprehensive discussion of the global market for neurointerventional cerebral aneurysm and AVM embolization systems. This market comprises the following product segments: endovascular coils, liquid embolics, stents for stent-assisted coiling, flow diversion and flow disruption systems, and other novel/emerging embolization devices. Markets covered by this analysis comprise the US, Japan, the five major European markets (France, Germany, Italy, Spain, and the UK), and the rest of world (RoW) markets. The forecast range for this report is 2020–25.

December 16, 2021

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Drug Firms Fear PBM ‘Discrimination’ Over List Price Reductions, Azar Tells Hearing

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Despite remarks from the US President to the contrary, US pharmaceutical companies have not yet voluntarily lowered their prices. Health and Human Services Secretary Alex Azar discusses the reasons why, and delves into the use of regulations as a means of prohibiting rebates in this illuminating article from Pink Sheet.

January 3, 2019

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European Commission Sheds Light On MDR/IVDR Progress In Vital Update

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The European Commission has finally released some long-awaited and eagerly anticipated deadlines for Medical Device Regulations and In Vitro Device Regulations implementation measures. The deadlines shed light on progress made by the EU Commission in this area, as application dates for regulations are quickly approaching.

October 18, 2018

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BSI Touts ‘Very Short’ Waiting Times For Migrating Certificates From UK To Netherlands

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UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit in March. Learn what this move would have meant to UK start-ups. Read the MHRA response to a Medtech Insight inquiry about the role of UK notified bodies after Brexit.

February 5, 2019

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Mortality Signal For Pfizer’s Xeljanz In Rheumatoid Arthritis Puts A Damper On JAK Class

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The cardiovascular risks associated with a higher-than-approved dose of Pfizer’s JAK inhibitor Xeljanz in a long-term rheumatoid arthritis study have raised questions about its other indications. Will the risk of pulmonary embolism for a higher unapproved dose of Xeljanz in arthritis trigger a label change in the drug’s other indications? Is the JAK-inhibitor class of therapies in jeopardy? Learn what the analysts are saying.

February 20, 2019

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