Legal & Regulatory

Efforts of the National Biomarker Development Alliance will address the 'dismal' success rate of approved biomarker diagnostics

Companies are positioning themselves as approved high-volume compounders

New 'emergent biopharma' service combines compliance with pricing, market access

Long-awaited track-and-trace law ushers in a new era of pharmaceutical supply-chain monitoring; compounding pharmacies get a new structure also

The growing complexity of managed-markets contract support makes outsourcing a near-necessity for Small Pharma, and a better option for Big Pharma

Bill includes voluntary oversight by FDA of outsourced compounded pharmaceuticals, national distributor licensure, and a timetable for serialization and drug tracking

The Medicare Part D switchover of 2007 is only a partial proxy for what the healthcare system will experience in the next several years

Results of a survey panel by QPharma, presented at PDMA Sharing Conference, show a wide spread of reactions and concerns over agg-spend rules

UDIs will be in place starting in late 2014, and rolling out over the next four years thereafter

While FDA dithers on regulatory guidance, state efforts to anticipate biosimilar regulation are mostly being rejected

Risk Evaluation & Mitigation Strategy (REMS) programs are evolving, with new complexities for compliance managers

Using real-world databases for evidence development has strengths and weaknesses; with electronic health records (EHRs), new approaches are evolving

Group passes the initial ICANN evaluation; will NABP be the international policeman of online pharmacies?

More compounding pharmacy recalls worsen the situation; FDA looks for new legislation

Academic study finds evidence of an early warning system in anonymized Web searches

Recent regulatory actions and court cases highlight the importance of due diligence in reporting the value of service fees when federal reimbursements are concerned. The financial consequences can be substantial

Number of cases opened by FDA's Office of Criminal Investigations (OCI) triples to 170

As the business grows at double-digit rates, representing its interests becomes its own business opportunity

A new policy debate over drug regulation is emerging as the NECC scandal worsens

As the number of adverse events (AEs) grows year by year, regulators and industry managers are looking at automated systems to handle the burden

Pricing systems in US drug supply chain have many limitations; an analytics-based method might avoid some of them

New incentives for health plans could alter the way payers review new drugs

As payers seek higher-quality data from real-world treatment settings, the importance of reliable measures becomes critical

New sample reporting requirements will be a focus of this year's meeting

Despite the lack of headlines today as compared to late last year, the drug-shortage situation has not improved. FDA, congressional and industry actions are beginning to change the dynamic

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

The 'Sunshine Act' provisions of the Affordable Care Act require records to be kept beginning Jan. 1

A combination of regulatory processes and business practices are worsening an already-bad drug shortage situation