Generic, brand companies have concerns about FDA's proposed drug shortage rule
In comments to the Food and Drug Administration, generic and brand drug companies said although they support the idea of notifying the agency of potential drug shortages, they have concerns with the agency's proposed rule. On Oct. 31, the FDA proposed a rule that would require drug manufacturers to report any supply chain disruptions (11 PLIR 1339, 11/8/13). The proposed rule, Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products, was called for under the FDA Safety and Innovation Act of 2012 (FDASIA). It was published in the Federal Register Nov. 4 (78 Fed. Reg. 65,904, Nov. 4, 2013), and comments were due Jan. 3.
- CFO Exchange: Smartphones Poised to Disrupt Healthcare, Says Topol
- CNO on Hospital Redesign: 'You Can't Over-Communicate'
- How Digital Strategy Shapes Patient Engagement at Boston Children's Hospital
- Half of All Primary Care, Internal Medicine Jobs Unfilled in 2013
- Consumerism Drives Healthcare Branding, Rebranding Efforts
- PA Ranks See 'Phenomenal Growth,' Lack of Diversity
- 3 Traits Personality Assessments Can't Reveal
- Carondelet to Pay $35M to Settle Fraud Allegations
- Some Cancer Hospitals' Quality Data Will Soon Be Public
- Antibiotic Overuse a 'Huge Threat' to Patient Safety, Says CDC