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Industry group says FDA botched COVID-19 convalescent plasma guidance

pharmaphorum

Bioindustry association MichBio says the FDA’s labelling requirements for COVID-19 convalescent plasma (CCP) – which were published alongside the emergency use authorisation – could lead to “hundreds, if not thousands, of in-date, ready to transfuse CCP units across the country being rendered unusable.”.

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Over-the-Counter Choices Pharmacist Role and Resources

FADIC

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. The FDA’s website provides a wealth of information on OTC drugs, including product labels, warnings, and recalls.

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NHC Submits Comments on FDA’s Draft Guidance for Voluntary Incorporation of Patient Preference Information

Putting Patients First Blog

Real-world case studies demonstrating how PPI has influenced decisions, such as targeted approvals or label modifications, would clarify its practical utility. 17 In addition to its role in pre-market decisions, PPI can be valuable in post-market activities, including the formulation and communication of recall notices. Viera, Nancy D.

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Tenaya’s cardiomyopathy gene therapy gets fast track boost

Pharmaceutical Technology

With this recent news, San Francisco-based Tenaya is initiating a multi-centre, open-label Phase Ib clinical trial for the drug. According to the Mayo Clinic, HCM refers to “a disease in which the heart muscle becomes thickened (hypertrophied)”. HCM is the most common inherited cardiac disorder.