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In a final guidance released Friday, the FDA adopted International Council for Harmonization (ICH) guidelines for three solvents used in drug manufacturing processes, based on the most up-to-date data on reproductive, genetic and carcinogenic toxicities. Read More
In a draft guidance released Friday, the FDA’s Center for Drug Evaluation and Research (CDER) offers advice for sponsors developing products for bowel cleansing prior to colonoscopy, suggesting the necessary attributes of patients for enrollment in clinical trials. Read More
In a 269-page report released Friday, the House Committee on Oversight and Reform challenges claims that high prescription drug prices are necessary to support innovation and details a slew of anticompetitive practices drugmakers have allegedly used in recent years. Read More
The individualized products should be from “a well-characterized chemical class for which there is substantial clinical and nonclinical experience,” the agency said. Read More
The settlement marks Allergan’s withdrawal from the ongoing trial in the Suffolk County State Supreme Court, leaving Teva Pharmaceuticals as the sole defendant. Read More
Minor changes to a drugmaker’s chemistry, manufacturing and controls (CMC) production processes for approved biologics must be documented in a yearly report, the FDA said in a final guidance released yesterday. Read More
In a draft guidance released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) offer advice for sponsors on the development of drugs or biological products for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Read More
Allergan has agreed to pay $200 million to resolve New York-based claims that it helped facilitate the state’s opioid crisis through deceptive marketing. Read More
The FDA has granted AstraZeneca’s long-acting antibody combination Evusheld an Emergency Use Authorization (EUA) for preventing COVID-19 in adults and children 12 years of age and older with weak immune systems. Read More