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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
The FDA chided OTC drugmaker Altaire for an inadequate response to numerous customer complaints of mold in the eye drop product carboxymethylcellulose sodium 0.5 percent ophthalmic solution, 30 mL. Read More
Merck KGaA’s Mexican subsidiary received a Form 483 for inadequately looking into a glass defect and not examining devices used in its products. Read More
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. Read More
The FDA Tuesday 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