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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 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
Pfizer subsidiary Meridian Medical Technologies is under continued pressure from the FDA to improve oversight and quality at its Missouri plants. Read More
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
The CMS Tuesday clarified a top concern of drugmakers: which format to use for submitting reports required under the Physician Payment Sunshine Act. Read More
The flurry of FDA guidance issued this week explaining to compounders how to work with the FDA is part of the agency’s full-on effort to make registration as appealing as possible to compounders who may worry that regulatory oversight will hamper business. Read More
In the latest initiative to clean up its troubled clinical trial industry, the Indian government is requiring investigators to video record the informed consent process for each subject in clinical studies. 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 Nov. 27 hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More
Sloppy investigations into various deviations such as hair in finished drug vials are outlined by the FDA in a Form 483 for OSO Biopharmaceuticals Manufacturing. Read More