Regulatory Updates-October 2020

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Swissmedic: Changeover to electronic submission of notifications of major changes: 1 November 2020

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FDA: The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls

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EMA: EMA starts first rolling review of a COVID-19 vaccine in the EU

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How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB)

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FDA: Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment

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Covid-19 delays to adoption of TGO 91 labels

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FDA: Emergency Use Authorization for Vaccines to Prevent COVID-19 (guidance for industry)

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FDA: Premenopausal Women with Breast Cancer: Developing Drugs for Treatment

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EMA: New online platform for scientific advice

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FDA: FAQs on Testing for SARS-CoV-2

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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

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FDA: Electronic Delivery of Premarket Submissions Pilot

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EMA: Questions and answers on Data Monitoring Committees issues

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FDA: FDA Should Strengthen Efforts to Provide Effective Oversight

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TGA: TGA grants provisional determination for Covid-19 vaccine

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TGA: The TGA’s approach to delays in medical device conformity assessment recertification Due to COVID-19 pandemic and delays in EU MDR implementation

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PMDA: PMDA Reveals Principles on Evaluation of COVID-19 Vaccines

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TGA: New transparency measures for prescription medicines

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TGA: Changing sponsor details in PI and labels

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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.

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TGA: TGA grants second provisional determination for a COVID-19 vaccine

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FDA: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

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UK: UK medicines regulator joins up with Australia, Canada, Singapore and Switzerland regulators

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Danish Medicines Agency: Extraordinary measures for clinical trials due to COVID-19

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EMA: Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)  (draft guidance)

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FDA: Testing for Biotin Interference in In Vitro Diagnostic Devices

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FDA: Technical Considerations for Nonclinical Assessment of Medical Devices Containing Nitinol

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FDA: Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin

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FDA: Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement

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FDA: Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement

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FDA: CDRH Proposed Guidances for Fiscal Year 2021 (FY 2021)

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EC: Information on actor registration module

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FDA: Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 (draft guidance)

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UK: Supply of unlicensed medicines between Northern Ireland and Great Britain after 1 January 2021

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Swissmedic: Swissmedic receives second application for the authorisation of a coronavirus vaccine

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UK: NIBSC selected by CEPI to test coronavirus vaccines globally

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FDA: FDA approves Remdesivir for COVID-19

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EMA: Reflection paper on the pharmaceutical development of medicines for use in the older population

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EC: Preliminary Opinion 16 on the safety of breast implants 17 in relation to anaplastic large cell lymphoma

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CDSCO: Regulating ultrasound equipment as drugs

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FDA: Referencing Approved Drug Products in ANDA Submissions

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EMA: Lessons learnt from presence of N-nitrosamine impurities in sartan medicines

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UK: Variations to Marketing Authorisations (MAs) from 1 January 2021

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UK: Guidance note on new assessment routes from 1 January 2021

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UK: Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs)

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Swissmedic: Discovery of new nitrosamine contamination in tuberculosis drugs: Swissmedic pushes clarification ahead

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FDA: A CDER Study of Factors that May Predict the Likelihood of Generic Drug Marketing Applications

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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

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EMA: Transparency: exceptional measures for COVID-19 medicines

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