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Many CHPA members also market medical devices "and the consumer side of medical devices is something they feel is underrepresented by other trade associations,” says trade group head Scott Melville. OTC drugs already have “a lot in common” with consumer medical devices, including that paying for neither typically is included in health insurance plans.
Eight EU marketing authorization applications are up for an opinion this week from the CHMP, the European Medicines Agency committee that recommends whether or not products should be approved.
Administration also plans to roll out slate of proposals to decrease drug prices and bring discounts to patients.
US FDA Pushes Back On Proposal For Early Clinical Designations To Support Higher Reimbursement Decisions
Drug Safety: Sequential Surveillance Helps Regulatory Decision-Making, But Hurt By Premature Specification
Dedicated mechanism may be needed for biopharma sponsors and patient advocacy groups to talk to agency about patient experience data collection and analysis; industry wants FDA to clarify where such data will appear in product labeling, while advocates ask agency to be mindful of limited resources many patient groups have for conducting such research.
As more highly potent and highly toxic drugs are being developed, regulators are looking into risks posed by contamination of non-contact surfaces, yet until recently, there was scant guidance on how to assess these risks.
The government is expecting to reap UK-wide savings of £33m by basing the statutory drug pricing scheme on regular payments on sales rather than price cuts and limiting the maximum prices companies can charge the NHS. The move will bring the scheme more into line with the voluntary PPRS.
China's third-ranked health official Ma Xiaowei has been promoted to the top position, leading an agency transforming itself from treating diseases to health policy-making against a backdrop of a fast-aging population, emerging data and new AI technologies.
IND Safety Reporting: Stakeholders Tussle Over Which Adverse Events To Report, Proper Oversight Body
US FDA officials, drug sponsors discussing creation of library of adverse event rates.
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