Johnson & Johnson (J&J) has settled “substantially all” of the thousands of Risperdal (risperidone)-related lawsuits filed in the U.S. — which had alleged that the company’s anti-psychotic drug caused males…
The FDA is taking more time to review Moderna’s COVID-19 vaccine in adolescents age 12 to 17 years over concerns the messenger RNA (mRNA)-based shot may be associated with increased…
After a delay in 2020, the FDA has launched its new NextGen Portal for drug manufacturers to use for reporting volume data for drugs and biologics. Source: Drug Industry Daily
In a Complete Response Letter to United Therapeutics, the FDA declined to approve the company’s Tyvaso DPI (treprostinil) drug-device combination for improving exercise capacity in patients with pulmonary arterial hypertension…
The FDA has released draft guidance on continuous manufacturing concepts for drug substances and drug products. Source: Drug GMP Report
The House of Representatives passed a bill in a bipartisan 368-56 vote on Oct. 19 that aims to promote innovation in continuous manufacturing, which is used to produce drugs more…
Teva Pharmaceutical stopped drug manufacturing at its Irvine, Calif., facility following a recent FDA inspection that revealed lapses, including possible mold contamination caused by water leaks. Source: Drug GMP Report
Cleaning and maintenance lapses feature among the deficiencies observed by FDA investigators during inspections of four drug facilities. Source: Drug GMP Report
The FDA issued warning letters to four drug manufacturing plants for failure to maintain good manufacturing practices — and to one firm for producing misbranded and unapproved drug products. Source:…
The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council…