Simplifying Global Compliance
Just days after the FDA’s new authorities over compounding pharmacies were signed into law, the agency last week issued draft guidances detailing how facilities register and report product information to the FDA. Read More
Congressional negotiators are working to hammer out a new federal budget proposal for fiscal 2014 and fiscal 2015, and a group of lawmakers hopes to use the budget deal to shield FDA user fee revenue from any across-the-board sequestration cuts. Read More
The FDA plans to launch a study examining how consumers view risk information in direct-to-consumer (DTC) prescription drug advertisements, the latest study delving into how drugmakers craft ads. Read More
With the new pharmaceutical track-and-trace law’s deadline for lot-level pedigrees looming, the FDA is still unclear about how it will regulate the complex requirement. Read More
After years of pressure from lawmakers and drugmakers, the Obama administration appears to be surrendering its push for a reduced seven-year exclusivity period for biologic drugs. Read More
The FDA’s head of communications Virginia Cox is leaving the agency in January to pursue other opportunities. 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
Pfizer subsidiary Meridian Medical Technologies is under continued pressure from the FDA to improve oversight and quality at its Missouri plants. Read More
The FDA wants Wockhardt to investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift an import ban it slapped on the plant Nov. 26. Read More
Following setbacks to its hepatitis C drug program, Idenix Pharmaceuticals is appealing to the courts to keep Gilead’s competing hepatitis C treatment off pharmacy shelves. Read More
The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction or postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying a citizen petition submitted by Square Pharmaceuticals. Read More
Eli Lilly’s plans for strong sales growth in 2014 have been set back, with the drugmaker saying Thursday its promising depression treatment edivoxetine has failed in late-stage testing. Read More
The FDA is building a list of difficult-to-manufacture drugs that compounders will not be allowed to make and is soliciting public suggestions for products to place on the list. Read More
The White House Office of Management and Budget’s decision to sequester nearly $85 million of FDA user fees is wrong, and should be reversed immediately, lawmakers say. 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
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
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 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
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