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A group of lawmakers wants the FDA to strip Zogenix’s opioid painkiller Zohydro ER of its approval until the company creates an abuse-deterrent formulation of the product. Read More
The FDA is maintaining pressure on Pfizer subsidiary Meridian Medical Technologies, a maker of drug auto-injectors, to improve quality at its Missouri plants. Read More
The FDA is demanding Wockhardt investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift the import ban it has slapped on the plant. Read More
The FDA’s proposed new labeling requirements for generics pose such a challenge to industry that GPhA has asked the FDA for an additional two months to comment on the proposed rule. Read More
Prosecutors appear ready to lean more heavily on the False Claims Act in prosecuting off-label marketing cases, sidestepping a ruling in the U.S. Second Circuit that found off-label promotion was protected free speech and not prosecutable under the 1938 FD&C Act. Read More
CDER Director Janet Woodcock has decided to head the FDA’s new Office of Pharmaceutical Quality (OPQ) herself until it gets off the ground. The new office is planned as a “super office” that will oversee manufacturing quality throughout a drug’s lifecycle. Read More
CDER Director Janet Woodcock has decided to head the FDA’s new Office of Pharmaceutical Quality (OPQ) herself until it gets off the ground. The new office is planned as a “super office” that will oversee manufacturing quality throughout a drug’s lifecycle. Read More
The FDA’s proposed new labeling requirements for generics pose such a challenge to industry that GPhA has asked the FDA for an additional two months to comment on the proposed rule. Read More
Several House members are calling on the FDA to strip Zohydro ER, Zogenix’s opioid painkiller, of its approval until the company can instill an abuse-deterrent formulation of the product. Read More
The FDA’s unusual demand that an importer of active pharmaceutical ingredients (API) list the distributors that might sell finished product created with the API has sparked a lawsuit that could further complicate U.S. border control processes. Read More
An agreement is expected to be reached on the Clinical Trial Regulation between EU lawmakers and the European Council by Christmas, and industry groups are asking to ensure the timelines for submissions are predictable and no longer than those already established in the current directive. Read More
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