Posted by FDA: Information about Nitrosamine Impurities in Medications
WHO: Corticosteroids for Covid-19
MHRA post-transition period information – Guidance for industry and organisations to follow from 1 January 2021
EMA: Preparedness of medicines clinical trials in paediatrics
FDA: Recommendations for Investigational COVID-19 Convalescent Plasma
FDA: Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing (draft guidance)
FDA: Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency
US HHS: Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act
FDA: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
TGA: Information for medicine advertisers: Additional allergen warnings effective 1 September 2020
TGA: Summary and outcomes: review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in Australia
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
CDSCO: Classification of non-notified medical device
Malaysia MDA: MEDICAL DEVICE GUIDANCE DOCUMENTCONFORMITY ASSESSMENT BODY (CAB) – REQUIREMENTS FOR REGISTRATION
Swissmedic: GMP/GDP inspections following the end of the extraordinary situation
FDA: Digital Health Software Precertification (Pre-Cert) Program
FDA: Recognition and Withdrawal of Voluntary Consensus Standards
EMEA: Support for industry on clinical data publication
HPRA: Good Distribution Practice of Medicinal Products for Human Use
HPRA: Wholesaling and Brokering of Medicinal Products for Human Use in Ireland
EMA: ICH guideline Q3D (R2) on elemental impurities
FDA: Geriatric Information in Human Prescription Drug and Biological Product Labeling (draft guidance)
CDSCO: Draft guidance for development of vaccines for Covid 19
Malaysia MDA: Policy on implementation and enforcement under the medical device act – Refurbishment of medical device
FDA: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
FDA: FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
FDA: Accreditation Scheme for Conformity Assessment (ASCA)
Swissmedic: Authorisation of medicinal products for the prevention and treatment of COVID-19
MHRA: Safety-critical alerts are changing at the MHRA
FDA: HHS issues final guidance on importing drugs from Canada
FDA: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
FDA: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
FDA: Breast Implants – Certain Labeling Recommendations to Improve Patient Communication
FDA: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
FDA: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (draft guidance)
TGA: Early scientific advice on biowaivers
Medsafe: Outcome of the consultation on the proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions