Biopharmaceutical company CStone Pharmaceuticals (HKEX:2616) reported on Friday the receipt of approval in Australia from the Human Research Ethics Committee Therapeutic Goods Administration
(TGA) as well as the electronic Clinical Trial Notification (eCTN) for the launch of the Phase I clinical trial of CS3002 in advanced cancer patients.
The Therapeutic Goods Administration
(TGA) has tested a product labelled Hong Kong Tianli Biological - Power tablets and found that:
Australia's Therapeutic Goods Administration
announced the proposed suspension of textured breast implants "on the basis that it is likely that there are grounds for cancelling the entries of the products." It explained, "Based on the laboratory and statistical review, the TGA has proposed regulatory action in relation to a number of textured implants only.
Camurus AB (STO:CAMX), a Swedish research-based pharmaceutical company, announced on Wednesday the approval by the Australian Therapeutic Goods Administration
(TGA) of the company's lead products Buvidal Weekly and Buvidal Monthly (CAM2038) for maintenance treatment of opioid dependence, within a framework of medical, social and psychosocial support.
The Deerfield-based company said the Evo IQ Infusion System will be marketed in the United Kingdom, Ireland and New Zealand and that it received regulatory approval by the Therapeutic Goods Administration
Celltrion said Sunday it has recently won approval from the Australia's Therapeutic Goods Administration
for the sale and marketing of Truxima, the Korean biopharmaceutical firm's cheaper biosimilar copy of Rituxan which was developed by Biogen and marketed by Roche.
Dr Amin Hussain Al Amiri, Assistant Under-Secretary for the Medical Practice and Licence Sector at the UAE Ministry of Health and Prevention and Chairman of the Supreme Committee for Pharmaceutical Vigilance, emphasised that messages, which were widely circulated on social media, stating that Brufen contains aluminium foil are completely baseless and the ministry has not issued any related safety alerts or received any warning from the United States Food and Drug Administration, the European Medicines Agency or the Therapeutic Goods Administration
SB4 has also received regulatory approvals from Korea's Ministry of Food and Drug Safety (MFDS), Australia's Therapeutic Goods Administration
(TGA), and Canada's Health Canada, as BRENZYS.
The nation's Therapeutic Goods Administration
(TGA) - in the same vein as the United States Food and Drug Administration - published its final decision.
Food and Drug Administration, ANVISA, Health Canada, and Australia's Therapeutic Goods Administration
. Other IMDRF agencies are in support of the initiative and some, including both Japan's Ministry of Health, Labour, and Welfare, and the Pharmaceuticals and Medical Devices Agency, will sit in as observers during the pilot program.
In May 2013 the Therapeutic Goods Administration
(TGA) commenced a consultative process on its proposed reforms to the advertising of therapeutic goods.
(OTCQX: CMXI) announced that its Angel cPRP System has been listed by the TGA (Therapeutic Goods Administration
) in Australia.