Legal / Regulatory
 
Manufacturers are reviving their serialization plans
The pioneering firms that installed serialization and track-and-trace systems are being joined by a fast follower crowd, but an industry-wide commitment is still in the future
Aggregate Spending Rules Arrive, But Industry Is Still Gearing Up
The 'Sunshine Act' provisions of the Affordable Care Act require records to be kept . . .
Drug Shortages Continue To Rise, With No Near-Term Resolution
A combination of regulatory processes and business practices are worsening an already-bad drug shortage situation . . .
Google Prepares for a Possible $500-Million Penalty for Illegal Online Pharmacy Advertising, Says WSJ
Dispute with US DoJ highlights role of NABP's Verified Internet Pharmacy Practice Sites (VIPPS) programs . . .
Aggregate Spend Laws: Here Comes the Sun
The industry is far from ready when it comes to collecting, aggregating, cleansing and disclosing data about regulated financial transactions with doctors and hospitals . . .
How REMS Affect Pharmaceutical Distribution Processes and Partners
First-ever study of the impact of REMS on supply chains finds that collaboration is a critical requirement . . .
Google Prepares for a Possible $500-Million Penalty for Illegal Online Pharmacy Advertising, Says WSJ
Dispute with US DoJ highlights role of NABP's Verified Internet Pharmacy Practice Sites (VIPPS) programs . . .
FDA's Social Media Enforcement: Emerging Rules of Engagement
The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have signaled that social media marketing is a priority . . .
FDA Opened 72 New Counterfeit Cases in 2010--a New Record
Caseload reinforces concerns over illegal trade and distribution of pharmaceuticals . . .
Adverse Event Reporting: At the Front Lines of Drug Safety
Industry and regulators are taking steps to revolutionize the basic regulatory function of collecting and analyzing adverse medical events . . .
 
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