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Rather than focusing solely on product and brand management, drugmakers are turning to patient-oriented efforts such as Rx compliance and disease management programs to increase revenue, according to a report from Cutting Edge Information.
Companies should not implement new SOPs without first training employees on the proposed change and documenting the training, according to Timothy Wells, founder of Wells & Associates and former leader of the Center for Devices and Radiological Health's quality system inspections reengineering team.
A dental laboratory in Costa Rica has a final chance to correct several quality system violations cited during a recent FDA inspection before the agency will take further regulatory action.
A face-to-face meeting between the FDA and company officials is the best way to resolve serious compliance problems if a company has received repeated warning letters, according to an official from the Center for Devices and Radiological Health (CDRH).
In Part IV of this series on implementation strategies for ISO 14971, Jeffrey Shaul offers advice on conducting risk assessments and choosing an appropriate risk assessment tool and Kevin Quinley discusses ways companies can protect themselves when their devices fail.
Failure to define and implement corrective and preventive action (CAPA) systematically is the biggest cause of CAPA system failures and affects a company’s entire quality system, according to Lisa Griffith, a business domain expert with NetRegulus.
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In a decision that overturns FDA policy, a federal judge has ruled that generic firm Apotex does not have to share its 180-day exclusivity period for a version of GlaxoSmithKline’s depression drug Paxil (paroxetine HCl) with rival firms.
Connecticut is going to investigate possible anticompetitive actions by Purdue Pharma in seeking and maintaining patents for the painkiller OxyContin and wants other states to join the probe, according to a spokesman for state Attorney General Richard Blumenthal.
Pharmaceutical firms must now inform federal antitrust watchdogs when they settle disputes over the launch of generic versions of brand drugs. The Federal Trade Commission (FTC) yesterday published a reminder to drugmakers that they have only 10 business days after reaching an agreement to file a copy with the commission and the Justice Department.