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Drug recalls in 2020 climbed to 344, a 2.4 percent increase from the previous year, although that small increase was overshadowed by the amount of drugs actually impacted by the recalls, a new report says. Read More
Alembic Pharmaceuticals, a sterile drug manufacturer in Gujarat, India, drew a Form 483 inspection report from the FDA with five observations following a Jan. 28 – Feb. 6 inspection. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to AcelRx Pharmaceuticals over false and misleading claims it made for its oral opioid Dsuvia (sufentanil). Read More
Drug recalls in 2020 climbed to 344, a 2.4 percent increase from the previous year, although that small increase was overshadowed by the amount of drugs actually impacted by the recalls, a new report says. Read More
Alembic Pharmaceuticals, a sterile drug manufacturer in Gujarat, India, drew a Form 483 inspection report from the FDA with five observations following a Jan. 28 – Feb. 6 inspection. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to AcelRx Pharmaceuticals over false and misleading claims it made for its oral opioid Dsuvia (sufentanil). Read More
Pfizer announced that its blockbuster rheumatoid arthritis drug Xeljanz (tofacitinib) failed to meet its primary endpoints in a postmarket safety study. Read More
The FDA has announced that it is investigating multiple reports of allergic reactions to Pfizer/BioNTech’s COVID-19 vaccine as supplies of the shot continue to roll out across the U.S. this week. Read More
McKinsey and Co. has taken the unusual step of apologizing for the consulting work it did for Purdue Pharma, which has entered into an $8 billion settlement with the Justice Department over its role in the opioid abuse crisis. Read More
The UK’s Drug Safety Research Unit (DSRU) is gearing up to start an active surveillance study of COVID-19 vaccines following the country’s emergency clearance of Pfizer’s highly effective coronavirus vaccine, the group announced. Read More
The FDA has developed two new documents that it wants drug sponsors to use for annual postmarket reporting and is requesting comments on them in a new draft guidance. Read More