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.
Seeking to clarify how manufacturers can “take advantage of new possibilities using innovative tools,” the European Commission has released the updated Annex 1 to its good manufacturing principles regulation, addressing manufacture of sterile products. Read More
The FDA levied import alerts on 49 manufacturing sites in fiscal year 2021 for refusing inspections or records requests, noncompliant laboratory testing and noncompliant findings from inspections and records requests — a marked decrease over a high of 128 import alerts issued in fiscal year 2020. Read More
FDA Commissioner Robert Califf highlighted the role the biomedical “ecosystem” should play in reversing the decline in life expectancy in the U.S. in a Science magazine editorial last week. Read More
The number of drug manufacturing facilities registered with the FDA has grown by an average of 3 percent worldwide since 2018, according to the FDA Office of Pharmaceutical Quality’s 2021 report, with the U.S. surging ahead with a 5 percent increase in facilities. Read More
Pfizer will ask the FDA to approve its respiratory syncytial virus vaccine, RSVpreF, based on phase 3 data showing that it prevented about 86 percent of severe disease. Read More
The FDA issued a warning letter to Tramadol US, calling on the company to stop selling prescription drugs, including opioids, directly to consumers on the 25 websites the company operates. Read More
A federal judge in California has ruled that Gilead Sciences must face a pay-for-delay lawsuit over alleged unlawful payments to India-based Cipla to block competition for Gilead’s former blockbuster HIV drug Truvada (emtricitabine, tenofovir disoproxil fumarate). Read More
Indivior must face a federal jury over allegations that it tried to maintain its monopoly on Suboxone by switching to a sublingual formulation just as other companies were launching generic versions of the opioid antagonist. Read More
Controversy often arises around FDA’s drug approval decisions when the system fails to produce reliable evidence of risks and benefits, says FDA Commissioner Robert Califf, alluding to recent criticism of the agency for bypassing advisory committee recommendations. Read More