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Focus on Regulation

Tag Archives: guidance

New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

1.            Introduction On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers and notified bodies and provides guidance on the presentation, content and validation of the SSCP under the Medical Devices Regulation

European commission publishes Additional Guidance regarding the Medical Devices Vigilance System

The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD), provide for the requirement for a European Medical Devices Vigilance System. The Medical Devices Vigilance System is the European system for the notification and evaluation of incidents

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic Medical Devices Regulation (“IVDR”). The MDR and IVDR will apply from May 2020 and May 2022 respectively. These documents include: Factsheet for

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives for innovators to invest in further research.  On July 19, FDA also published the guidance “Labeling for Biosimilar Products,” finalizing an April

FDA proposes new ways for prescription drugs to become available over-the-counter

On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a prescription, drugs that are currently available only by prescription.  The draft guidance would facilitate these prescription (Rx) to Over-The-Counter (OTC) switches by allowing

New version of EMA’s pre-authorisation procedural advice for the centralised procedure released

On 4 May 2018, the European Medicines Agency (“EMA”) published another updated version of the guidance document on pre-authorisation for users of the centralised procedure. The document contains revisions regarding the EMA marketing authorisation application numbers. It also includes changes related to oral explanations during the assessment procedure of the marketing authorisation application. Background The

EMA Publishes New GMP Guidance on Data Integrity

The European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance concerning measures intended to ensure data integrity throughout the “data lifecycle” from generation of data, processing, use in decision making, to disposal. The document provides a set of frequently asked questions and answers for companies that process data generated in the process

Product Design and Safety Considerations

The FDA issued its final guidance for the industry on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors, three years after the draft was first published.

FDA Notifies Applicants of Intent to Require Sweeping Changes to Labeling for IR Opioid Analgesics and Entire Class of Prescription Opioids

FDA has announced its intent to require new class-wide labeling requirements for immediate-release (IR) opioid pain medications including new black and other safety warnings.  The enhanced warnings are intended “to inform prescribers and patients of additional risks related to opioid use.”  FDA, News Release (March 22, 2016) (hereinafter, “News Release”).  FDA further announced its intent

EMA’s new guidance on publication of clinical data

On 3 February 2016 European Medicines Agency (“EMA’s”) introduced new External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use(“the New External Guidance”).

EMA Updates Product Information Templates for Medicinal Products for Human Use

On 10 June 2015, the European Medicines Agency published the revised Human Product Information templates for medicinal products in the European Union (“EU”). The revised Quality Review of Documents (“QRD”) template concerning centralised procedures is most notably affected by this update. The update introduces certain modifications to the Human Product Information template and is intended

Clarifying the duty to have regard

The High Court has found that the duty “to have regard to” guidance requires that guidance to be taken into account, and for there to be “clear” reasons for any departure from it, but that it does not go so far as to require a “compelling justification” for a departure. The recent case of R

EMA publishes draft guidance on medication errors for public consultation

On 14 April 2015, the European Medicines Agency (“EMA”) published three draft guidance documents concerning medication errors for consultation. The new European Union (“EU”) laws and regulations governing pharmacovigilance activities require reports of suspected adverse reactions arising from an error associated with the use of a medicinal product to be reported to EudraVigilance. To support

FDA Announces Enforcement Discretion in Implementing the DSCSA’s Product Tracing Requirements, Delaying Enforcement until May 1, 2015

FDA recently issued a Guidance document announcing that it will exercise its discretion not to enforce the product tracing requirements of the Drug Supply Chain Security Act (DSCSA) until May 1, 2015.  The Guidance, entitled DSCSA Implementation:  Product Tracing Requirements — Compliance Policy, is being implemented immediately.  Under the DSCSA, the product tracing requirements for

Revisions to European Medicines Agency Guidance on Good Pharmacovigilance Practices in Adverse Event Reporting

On 16 September 2014, new revisions to the European Medicines Agency (“EMA”) guidance on good pharmacovigilance practices came into effect. The EMA provides guidance on good pharmacovigilance practices (“GVP”) to facilitate the performance of pharmacovigilance in the European Union (“EU”). They apply to marketing authorisation holders, the EMA and competent authorities in EU Member States.

FDA Proposes Enforcement Discretion for Medical Device Data Systems, Medical Image Storage Solutions, and Medical Image Communications Devices

In a 20 June 2014 draft guidance, the Food and Drug Administration (FDA or Agency) proposed that, once the guidance is finalized, the Agency would refrain from enforcement of all regulatory requirements for a subset of hardware and software that transfers, stores, converts, formats, and displays medical device data or medical imaging data, which would

New Borderline Guide concerning medical devices issued by the MHRA

On 5 February 2014, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance document[1] intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices. In its guidance, the MHRA underlines that a product will be

U.S. Department of Transportation Issues Updated Guidance related to Charters

 The U.S. Department of Transportation has issued updated guidance regarding charter prospectus filings and charter operations.  This latest guidance was reportedly meant to address the inconveniences and issues that arose in connection with charter operator Direct Air’s cessation of service. Notice 380 jan14 2 website (5)  In addition, the Department has prepared draft “assurances” that will