We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six different indications. Read More
Robert Califf was sworn in as the new commissioner of the FDA Feb. 25 after the Senate confirmed him on Feb. 24 in a roll call vote of 89 to 4. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More
The Kentucky state Senate has passed a bill in a 36 to 1 vote that would permit interchangeable biosimilar substitution. The FDA has not yet approved an interchangeable biosimilar. Read More
Drugmakers producing hormones should consult with the FDA before seeking to opt out of an environmental assessment because of the impact of those drugs on the water supply. Read More
The FDA has updated its list of scheduled guidances for the calendar year 2016, with a major focus on pharmaceutical quality, data integrity and generics. There are 102 planned guidances this year, compared with 92 last year. Read More