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Biological manufacturers should submit their lot distribution reports (LDRs) using the same electronic messaging standard as those used for drug registration and labeling content of BLAs, says a new draft guidance on LDR electronic submissions. Read More
The FDA has added flow charts and removed references to the now-defunct CDER Fax-On Demand system in its updated policy on how the agency goes about posting approval letters for new NDAs, ANDAs, BLAs and supplements. Read More
Biogen Idec said it will launch its multiple sclerosis drug Tecfidera within three months in England and Wales following a final coverage recommendation this week from the UK healthcare pricing watchdog. Read More
Boehringer Ingelheim and Eli Lilly’s type 2 diabetes drug Jardiance has received a preliminary thumbs-down from the UK’s healthcare cost watchdog, which wants to see more cost-effectiveness data comparing the new product with other existing treatments. Read More