FDA Releases Updated RTA Checklist

The guidance replaces the 30 October 2017 draft guidance of the same name and describes the administrative steps will take to either Refuse to Accept (RTA) or file a request for an evaluation of automatic class III designation (De Novo request).

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General Drug Controller of India

All approvals from the Controller General of India (DCGI) will go completely online to ensure to global as well as domestic players, according to V G Somani, DCGI.

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to Ship With QR Codes

In an attempt to ensure authenticity, every active pharmaceutical ingredient (API) manufactured or imported in the country will soon bear a quick response or QR code on its label to facilitate tracking.

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Roundup: India Forms Technical Advisory Group to Help

Australia’s Goods Administration (TGA) has revealed that parts of the industry objected strongly to its recently adopted standard for tablets and .

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The Union health ministry has constituted a committee which will advise the Central Standard Control (CDSCO) regarding the strengthening of medical devices regulations in the country and also examine issues relating to their implementation.

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