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CDER Director Janet Woodcock flagged 2019 as a strong year for novel drug approvals, although the total dipped to 48 from the ten-year record of 59 for 2018. Read More
Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read More
Altaire Pharmaceuticals drew a 31-page Form 483 from the FDA for numerous failures related to contamination, laboratory controls and cleaning. Read More
So far major pharmacies are silent on a new federal court order for CVS Health, Rite-Aid, Walgreens, Walmart and other pharmacy defendants in the nationwide opioid multidistrict litigation (MDL) to submit 14 years of opioid dispensing data. Read More
Big-name drug companies have already increased their list prices for more than 300 brand-name drugs in the new year, marking another year of early January price hikes. Read More
Quality shortcomings including rusty equipment and data integrity lapses drew a warning letter from the FDA for GPT Pharmaceuticals’ facility in Hyderabad. Read More