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Brazil's Anvisa issued a rule on June 18 establishing criteria for the priority review of small molecule drugs and biologics. Rule No. 37 applies to marketing authorization, postauthorization and clinical study applications. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More
Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn't manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker. Read More
Baxter continues to be plagued with particulate problems, recalling two lots of a dialysis solution and a lot of saline solution that is currently in short supply. Read More
European regulators warn that the lactation-control drug bromocriptine should only be used for compelling medical reasons, and should not be used routinely for preventing or stopping milk production after childbirth. Read More
A federal court has ruled that generic manufacturer Mylan does not have to recall its already-shipped versions of Hospira’s sedative Precedex, a move that reverses the court’s earlier mandate to recall all existing generic versions of the drug. Read More
The FDA has cleared GlaxoSmithKline’s asthma drug Arnuity, adding a fourth product to GSK’s growing portfolio of respiratory drugs administered through its dry-powder inhaler Ellipta. Read More
Indian generics maker Dr. Reddy’s Laboratories is under investigation for allegedly selling prescription drugs without sufficient child-resistant packaging, the company revealed. Read More
Pharmaceutical companies should boost their efforts to collect and analyze demographic subgroup data in clinical trials, including by ensuring studies have enough women, minorities and elderly patients to be consistent with disease prevalence, the FDA has suggested. Read More
Certain general safety testing requirements may no longer be necessary to help ensure the safety, purity and potency of licensed biological products, the FDA said. Read More
In a widely expected move, the Drug Enforcement Administration has clamped down on misuse of hydrocodone combination products (HCPs) by classifying them as Schedule II controlled substances, a designation that already applies to oxycodone and non-combo hydrocodone painkillers. Read More