Contribuiamo al successo delle aziende di Dispositivi Medici e Diagnostici in Vitro negli Stati Uniti ed in Europa
Siamo esperti riconosciuti nella gestione di studi clinici su Dispositivi Medici, IVD e Combination Products in Europa, Stati Uniti e Canada.
Da oltre 20 anni Donawa Lifescience Consulting (DLC) offre consulenza regolatoria specializzata
ed altamente qualificata nel settore dei Dispositivi Medici, inclusi i Combination Products
e gli ATMPs (Advanced-therapy medicinal products). DLC può
agire inoltre come mandatario europeo (Authorized Representative) per fabbricanti con sede legale extra europea.
Diagnostici in Vitro
Diagnostici in Vitro
Da oltre 20 anni Donawa Lifescience Consulting (DLC) offre consulenza regolatoria
specializzata ed altamente qualificata nel settore Dispositivi Medici,
inclusi i Diagnostici in Vitro (IVD). DLC può agire inoltre come
mandatario europeo (Authorized Representative) per fabbricanti con sede
legale extra europea.
Esistono molte differenze tra le normative europee e statunitensi sui
Combination Products e i dispositivi drug-delivery. Donawa Lifescience
Consulting ( DLC ) puo fornire consulenza strategica per identificare
tali differenze così da permettere il raggiungimento delle varie
tappe dello sviluppo del prodotto nel rispetto dei tempi previsti.
FDA announces large hike in device user fees for FY 2018
29 August 2017
Following President Trump's signing into law of the bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for drugs, biosimilars and medical devices through 2022, the agency has now published the fees for device-related interactions with FDA. The new fees, which become effective from 1 October 2017, reverse the trend from the previous few years, which saw a small reduction in fees, with 510(k) fees doubling, and a new high fee being introduced for de novo 510(k) applications. Significant discounts apply for small businesses (turnover less than $100M), however.
The new fees (as corrected by FDA on 29 August 2017) are:
‡ Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.
Copies of the 'FY 2018 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments', can be obtained from here.
19 cities vie for EMA after Brexit
4 August 2017
The European Commission has received 19 offers from European cities to host the European Medicines Agency's (EMA) headquarters as it moves from London's Canary Wharf following Britain's decision to leave the EU. A final decision on the new location will be taken at the General Affairs Council and announced on 20 November 2017. The cities that have applied to host the EMA as of 1 August 2017 are:
The Commission's assessment will be based on six criteria agreed to by the 27 member states, including operationality guarantees (the availability of appropriate offices), location accessibility (which includes the frequency and duration of flight connections), schools for EMA staffers' children (including the availability of multi-lingual schools), access to the labour market and health care for staffers' families, business continuity (to maintain and attract highly qualified staff) and geographical spread.
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