FDA to Consider Expanding Scientific Exchange
At the 2014 FDLI Annual Conference, senior officials at FDA noted that the agency is not taking lightly industry's concerns…
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FDA Relaxing Controls on Imported Products for 13 Pharmaceutical Companies
The Food and Drug Administration (FDA) is loosening the regulatory controls for 13 pharmaceutical companies that will…
HHS-OIG Releases Updated Advisory on Independent Charity Patient Assistance…
Back in 2005, OIG concluded that pharmaceutical manufacturer patient assistance programs (PAPs) that subsidize Part D…
Pakistan Looks to Increase Transparency between Healthcare Providers and…
Pakistan may be the latest country onsidering increasing transparency in interactions between healthcare providers and industry.…
Physician Payments Sunshine Act: Phase 2 Data Submission and Attestation…
On June 1, applicable manufacturers and applicable group purchasing organizations (GPOs) will start Phase 2 of Open…
DC Transparency Law: Companies Won’t Have to Report Payments Made to DC…
The District of Columbia's AccessRX Act of 2004 has required pharmaceutical companies to report their marketing…
Supreme Court Declines to Review Important False Claims Act Issue
In our February article, Will Sunshine Data Help Qui Tam Whistleblowers and Their Attorneys?, we mentioned that while…
FDA Seeks Comment on New Draft Guidance for Biosimilars: “Clinical…
The Affordable Care Act amended the Public Health Service Act (PHSA) to include an abbreviated approval pathway for biological…
Physician Payments Sunshine Act: No Word Yet From CMS on Phase 2, Which…
As we've written numerous times now, the Centers for Medicare and Medicaid Services (CMS) split company submissions of…
Maintenance of Certification: Petition to Recall ABIM’s MOC Requirements…
The rally against Maintenance of Certification (MOC) continues as more and more doctors have signed a petition to recall…