Regulatory Updates-September 2020

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FDA: Information about Nitrosamine Impurities in Medications

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WHO: Corticosteroids for Covid-19

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MHRA post-transition period information – Guidance for industry and organisations to follow from 1 January 2021

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EMA: Preparedness of medicines clinical trials in paediatrics

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FDA: Recommendations for Investigational COVID-19 Convalescent Plasma

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FDA: Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing (draft guidance)

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FDA: Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

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US HHS: Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act

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FDA: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

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TGA: Information for medicine advertisers: Additional allergen warnings effective 1 September 2020

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TGA: Summary and outcomes: review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in Australia

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FDA: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

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CDSCO: Classification of non-notified medical device

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Malaysia MDA: MEDICAL DEVICE GUIDANCE DOCUMENTCONFORMITY ASSESSMENT BODY (CAB) – REQUIREMENTS FOR REGISTRATION

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Swissmedic: GMP/GDP inspections following the end of the extraordinary situation

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FDA: Digital Health Software Precertification (Pre-Cert) Program

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FDA: Recognition and Withdrawal of Voluntary Consensus Standards

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EMEA: Support for industry on clinical data publication

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HPRA: Good Distribution Practice of Medicinal Products for Human Use

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HPRA: Wholesaling and Brokering of Medicinal Products for Human Use in Ireland

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EMA: ICH guideline Q3D (R2) on elemental impurities

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FDA: Geriatric Information in Human Prescription Drug and Biological Product Labeling (draft guidance)

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CDSCO: Draft guidance for development of vaccines for Covid 19

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Malaysia MDA: Policy on implementation and enforcement under the medical device act – Refurbishment of medical device

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FDA: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

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FDA: FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products

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FDA: Accreditation Scheme for Conformity Assessment (ASCA)

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Swissmedic: Authorisation of medicinal products for the prevention and treatment of COVID-19

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MHRA: Safety-critical alerts are changing at the MHRA

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FDA: HHS issues final guidance on importing drugs from Canada

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FDA: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use

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FDA: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

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FDA: Breast Implants – Certain Labeling Recommendations to Improve Patient Communication

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FDA: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

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FDA: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (draft guidance)

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TGA: Early scientific advice on biowaivers

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Medsafe: Outcome of the consultation on the proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions

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