A new FDA draft guidance recommends sponsors include new class labeling and prescribing information for combined hormonal contraceptives containing estrogen and progestin. Source: Drug Industry Daily
Kmart agreed to pay a $32.3 million settlement over charges that its in-store pharmacies failed to report discounted drug prices to federal programs and, therefore, were reimbursed at inflated prices.…
Six U.S. senators called on the Drug Enforcement Administration to update regulations on partial filling of Schedule II drugs to help address the opioid addiction crisis. Source: Drug Industry Daily
FDA released two guidance documents focusing on communications between the agency and drug developers to make drug development more efficient and to help sponsors avoid costly delays. Source: Drug Industry…
The FDA cited Impax Laboratories after an inspection revealed a significant discrepancy in the operational qualification of its packaging line’s tablet counter/elevator. Source: Drug Industry Daily
The PTO’s Patent Trial and Appeal Board dismissed a patent owner’s claims of sovereign immunity from the proceedings — in a move that might have implications for Allergan’s Restasis patent…
The FDA is mandating a new class warning and labeling changes for all gadolinium-based contrast agents — as well as requiring manufacturers to conduct additional human and animal safety studies.…
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Source: Drug Industry Daily
The FDA issued a warning letter to Deserving Health International after an inspection of the drug manufacturer’s facility in Richmond, British Columbia in July revealed sterility problems, failure to verify…
In a result that could have far-reaching implications for brand-name drug manufacturers, the California Supreme Court unanimously ruled Novartis can be held liable for injuries caused by generics of its…