Regulatory

Sep 01, 2007
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Much has been said about the need and imperative for life science companies to comply with the various laws and regulations that govern our industry. More recently, state-level marketing laws have proliferated, adding new rules of the road and resulting in thousands of hours and millions of dollars for training, tracking, reporting, consulting, analysis, and support systems.
Sep 01, 2007
Pharmaceutical Executive
The history of prescription drug laws is a complex mix of evolution and politics—in particular, the politics following real or perceived public health crises. The bipartisan PDUFA IV legislation currently pending in Congress is no exception: The bills—the Senate FDA Revitalization Act (S. 1082) and the House FDA Amendments Act (H.R. 2900)—would both continue existing programs and create new regulatory burdens.
Jul 30, 2007
Pharmaceutical Executive
Twelve years is probably "the best deal the industry is going to get," comments former FDA official Scott Gottlieb. "This is a genuine compromise."
Jul 03, 2007
Pharmaceutical Executive
By Pharmaceutical Executive Editors
We'll see a more coordinated, worldwide platform not just for marketing, but for R&D and regulatory because of the harmonization that is slowly coming, primarily between Japan, Europe, and the United States
Jul 03, 2007
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Although pricey, serialization with RFID is expected to reduce logistical errors and address some aspects of supply chain security
Jun 01, 2007
Pharmaceutical Executive
There's tremendous opportunity for us to understand how drugs can be used even better to get the right outcome, not only how to contain them in order to avoid complications or adverse events
May 01, 2007
Pharmaceutical Executive
Innovation in science is no quick trick, and neither is collaboration. Back in March 2004, FDA sounded a now-famous alarm: Despite the drug industry's 250 percent jump in spending on R&D, drug-development productivity had plunged by 50 percent over the previous decade. The report, which became known as the Critical Path Initiative (CPI), last year yielded an industry-wide call to arms regarding 76 action items (aka, the "Opportunities List") in six key areas: biomarker development, the streamlining of trials, the harnessing of informatics, improving drug manufacturing, public health initiatives against infections and bioterrorism, and special programs for adolescents, children, and other at-risk populations.
May 01, 2007
Pharmaceutical Executive
By Pharmaceutical Executive Editors
As the industry focuses its attention on the upcoming renewal of the Prescription Drug User Fee Act (PDUFA), there is a tendency to overlook two other significant pharmaceutical programs coming up for renewal and a related piece of legislation that has been introduced:
Apr 01, 2007
Pharmaceutical Executive
The Sarbanes-Oxley Act—or SOX, as it is dubbed (not always so affectionately)—requires companies to provide greater control and quality assurance across a vast spectrum of business processes. In practice, SOX plays out differently industry by industry and even company by company. But for pharma, one of the most pressing consequences is the need to improve the accuracy of revenue recognition.
Feb 01, 2007
Pharmaceutical Executive
Democrats want more transparency from pharma, and Republicans also are making noise about pricing. But government drug reimbursement is hard to get right and often creates perverse patient care incentives.
native1_300x100
lorem ipsum