Legislation Regulation & Policy

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US House Panel Approves Medicare Hearing, Dental And Vision Coverage; Senate Bill Introduced

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Three bills that would cover eye, dental and hearing examination for US Medicare beneficiaries were passed by the US House Ways and Means Committee on 22 October and there is a similar bill in the Senate. Medtech Insight looks at the next steps for these House bills and the related Senate bill.
September 2, 2019
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Schakowsky’s Loaded Cosmetics Bill Described as ‘Floor, Not a Ceiling’ for States to Build On

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The Safe Cosmetics and Personal Care Products Act reintroduced to the US House of Representatives calls for greater duties and resource demands on companies and the FDA than the proposed Personal Care Act in the Senate and allows room for states to impose more stringent regulations.
September 2, 2019
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Anti-Aging Cosmetics Or Unlawfully Marketed Drugs? Two Federal Court Cases To Watch

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Skin-firming and anti-wrinkle claims on products marketed as cosmetics are being tested in California federal course. The results will have considerable implications on the health, beauty and wellness industry. HBW looks at similarities and differences of the two cases.
September 2, 2019
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Testing Ranitidine with Too Much Heat Could Generate NDMA, FDA Say

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The US Food and Drug Administration says reports of high levels of N-nitrosodimethylamine in the histamine-2 blocker ranitidine resulted from a third-party laboratory’s use of the incorrect test for the drug treatment. HBW covers the recommended testing method.
September 2, 2019
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Can Novartis Reclaim Pioneering Role In Transplantation?

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Novartis is developing a new type of immunosuppressive agent, an anti-CD40 monoclonal antibody, which might allow organ transplants to last longer in recipients, reduce pressure on transplant waiting lists, and improve long-term outcomes. In Vivo interviewed Novartis’ Head of Immunology, Hepatology and Dermatology.
September 2, 2019
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EMA under Pressure again as Staff Losses Worsen

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Higher than expected staff losses at the European Medicines Agency due to the relocations to Amsterdam are posing challenges to implement new EU legislation. While the planned move to a permanent HQ in the Dutch capital has led to a decrease in staff, the agency is having to further prioritize its business activities.
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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Top 10 Drugs: Biologic Blockbusters And The Biosimilar Threat

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Pharma companies faced a “patent cliff” a decade ago with generic competition threatening to slash sales of certain blockbusters. The new threat is biosimilars. Scrip shows how some mature cancer and autoimmune biologics are still the major drivers of revenues, and how biosimilars are gaining on them.
August 9, 2019
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Top 10 Drugs: Weighing Pharma’s Golden Eggs

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A relatively small number of costly drugs account for a sizable portion of pharma industry revenues. This informative and easily scannable Scrip infographic shows which drugs are the golden eggs, which companies are behind them, and how the landscape has changed in the past decade.
August 6, 2019
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Commission Would Back Limited Expansion Of Products Covered By MDR Grace Period

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After much speculation and urges of caution related to whether the European Commission would support a proposal to expand the range of products covered by the Medical Device Regulation’s four-year grace period, the European Commission has now said it will support it.
August 3, 2019
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New Age Thinking: US FDA’s Temple Sees Third Era Of Drug Development

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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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US FDA’s Rush Following Novartis’ Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation

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The FDA’s early release of inspection findings of a testing lab’s possible involvement in data falsification in the testing (and subsequent FDA approval) of Zolgensma is unusual, signaling the likelihood that Novartis will face tough scrutiny of its actions – and perhaps stiff fines because of the fraud. Learn why one analyst is alluding to the possibility of a government investigation on the call Novartis held for the investment community, and why he’s calling for corporate officers to be held liable for statue violations, regardless of whether they knew of any wrongdoing.
August 2, 2019
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CBD Suits Challenge ‘THC-Free’ Claims After Users Fail Drug Tests; Plaintiffs Bar May Just Be Warming Up

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Attorneys are warning CBD product marketers to be on guard for litigation challenging the authenticity of their claims, the safety of their products and other aspects of their businesses – this after users in the US filed suit as a result of testing positive for THC, which they attribute to defendants’ purportedly THC-free cannabidiol products. So far, suits of this nature have been limited in the US, but the few known cases could be the first waves of an impending tsunami to come. Was it false advertising on the part of the defendants, or did they not know their claims of THC-free CBD products to be untrue? In either case, the cost of litigation could be steep.
August 2, 2019
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‘Project Orbis’ Oncology Pilot Eventually Will Target ‘Major Impact’ Applications

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The US Food and Drug Administration’s Oncology Center of Excellence will hand-select applications to enroll in its “Project Orbis” multi-national parallel review pilot program. Pink Sheet covers how the FDA will focus on applicants that are expected to have a major impact on the standard of care.
August 2, 2019
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Patients’ Preferred Endpoints May Not Satisfy Regulatory Needs, US FDA Says

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At a meeting of mitochondrial disease drug development, officials of US Food and Drug Administration said that just because a measure is relevant to the patient community does not mean it can capture meaningful change in a clinical trial. Pink Sheet looks at the implications to sponsors.
August 2, 2019
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