Posted by Swissmedic: Changeover to electronic submission of notifications of major changes: 1 November 2020
FDA: The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls
EMA: EMA starts first rolling review of a COVID-19 vaccine in the EU
How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB)
FDA: Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment
Covid-19 delays to adoption of TGO 91 labels
FDA: Emergency Use Authorization for Vaccines to Prevent COVID-19 (guidance for industry)
FDA: Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
EMA: New online platform for scientific advice
FDA: FAQs on Testing for SARS-CoV-2
FDA: Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing – Letter to Health Care Providers
FDA: Electronic Delivery of Premarket Submissions Pilot
EMA: Questions and answers on Data Monitoring Committees issues
FDA: FDA Should Strengthen Efforts to Provide Effective Oversight
TGA: TGA grants provisional determination for Covid-19 vaccine
TGA: The TGA’s approach to delays in medical device conformity assessment recertification Due to COVID-19 pandemic and delays in EU MDR implementation
PMDA: PMDA Reveals Principles on Evaluation of COVID-19 Vaccines
TGA: New transparency measures for prescription medicines
TGA: Changing sponsor details in PI and labels
FDA: MAPP establishes the policies and procedures of the Office of Generic Drugs (OGD) for responding to suitability petitions submitted to it by or on behalf of prospective abbreviated new drug application (ANDA) applicants.
TGA: TGA grants second provisional determination for a COVID-19 vaccine
FDA: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
UK: UK medicines regulator joins up with Australia, Canada, Singapore and Switzerland regulators
Danish Medicines Agency: Extraordinary measures for clinical trials due to COVID-19
EMA: Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) (draft guidance)
FDA: Testing for Biotin Interference in In Vitro Diagnostic Devices
FDA: Technical Considerations for Nonclinical Assessment of Medical Devices Containing Nitinol
FDA: Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
FDA: Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement
FDA: Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement
FDA: CDRH Proposed Guidances for Fiscal Year 2021 (FY 2021)
EC: Information on actor registration module
FDA: Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 (draft guidance)
UK: Supply of unlicensed medicines between Northern Ireland and Great Britain after 1 January 2021
Swissmedic: Swissmedic receives second application for the authorisation of a coronavirus vaccine
UK: NIBSC selected by CEPI to test coronavirus vaccines globally
FDA: FDA approves Remdesivir for COVID-19
EMA: Reflection paper on the pharmaceutical development of medicines for use in the older population
EC: Preliminary Opinion 16 on the safety of breast implants 17 in relation to anaplastic large cell lymphoma
CDSCO: Regulating ultrasound equipment as drugs
FDA: Referencing Approved Drug Products in ANDA Submissions
EMA: Lessons learnt from presence of N-nitrosamine impurities in sartan medicines
UK: Variations to Marketing Authorisations (MAs) from 1 January 2021
UK: Guidance note on new assessment routes from 1 January 2021
UK: Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs)
Swissmedic: Discovery of new nitrosamine contamination in tuberculosis drugs: Swissmedic pushes clarification ahead
FDA: A CDER Study of Factors that May Predict the Likelihood of Generic Drug Marketing Applications
FDA: Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures
EMA: Transparency: exceptional measures for COVID-19 medicines