Drug GMP Report

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 GMP Report

Dercher Enterprises of Upper Darby, Pa., doing business as Gordon Laboratories, was hit with an eight-observation Form 483, and the company’s new quality director told FDAnews that he’s working to pull the company into full compliance. Source: Drug GMP Report

The FDA has closed out its three-year-old warning letter to Zhejiang Huahai Pharmaceutical’s site in Linhai, Taizhou because of corrective actions the manufacturer has undertaken. Source: Drug GMP Report

Following a year in which vaccine manufacturing plant Emergent BioSolutions spent many months in the headlines for botching 75 million Johnson & Johnson (J&J) COVID-19 vaccines, the federal government and the troubled company have parted ways. Source: Drug GMP Report

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 and pulmonary hypertension associated with interstitial lung disease. Source: Drug GMP Report

The FDA has released draft guidance on continuous manufacturing concepts for drug substances and drug products.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 efficiently than the conventional batch production process. Source: Drug GMP Report

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: Drug GMP Report