As the U.S. healthcare system continues to undergo a transformation, we find ourselves at a critical inflection point for investment in pharmaceutical innovation. Stakeholders frequently cannot reach consensus on what constitutes "value" and how to support it, and no uniform, transparent, or predictable evidence threshold exists to ensure wholesale market access.
CLIA (Clinical Laboratory Improvement Amendments) passed by Congress in 1988 (Federal Register, 1992), is an increasingly key requirement for clinical research laboratories that provide human-derived sample testing. These evaluations derive information on the diagnosis, treatment, and prevention of disease, impairment or assessment of human health conditions. CLIA certification is an affirmation of the laboratory testing quality standards to ascertain patient test result accuracy, reliability and timeliness.
CLIA (Clinical Laboratory Improvement Amendments) passed by Congress in 1988 (Federal Register, 1992), is an increasingly key requirement for clinical research laboratories that provide human-derived sample testing. These evaluations derive information on the diagnosis, treatment, and prevention of disease, impairment or assessment of human health conditions. CLIA certification is an affirmation of the laboratory testing quality standards to ascertain patient test result accuracy, reliability and timeliness.
The federal Controlled Substances Act was enacted to create a comprehensive system to prevent the diversion, misuse and abuse of certain drugs and substances. Along with complementary laws enacted in almost every state, this law restricts the handling of such substances. It creates a closed chain of distribution to reduce the potential for diversion of legitimate medicines.
CLIA (Clinical Laboratory Improvement Amendments) passed by Congress in 1988 (Federal Register, 1992), is an increasingly key requirement for clinical research laboratories that provide human-derived sample testing. These evaluations derive information on the diagnosis, treatment, and prevention of disease, impairment or assessment of human health conditions. CLIA certification is an affirmation of the laboratory testing quality standards to ascertain patient test result accuracy, reliability and timeliness.
The federal Controlled Substances Act was enacted to create a comprehensive system to prevent the diversion, misuse and abuse of certain drugs and substances. Along with complementary laws enacted in almost every state, this law restricts the handling of such substances. It creates a closed chain of distribution to reduce the potential for diversion of legitimate medicines.
CHI-California Healthcare Institute, in collaboration with Merrill DataSite, invite you to a complimentary, 75-minute webinar discussing the new FDA user fee law...
Medical writers don't just prepare regulatory documents used to pursue FDA approval for drugs and devices. Many help doctors write research articles, produce educational materials and slides. Medical writers produce sales training materials, press releases, and marketing materials. They also write for newsletters, magazines, and newspapers. Medical writers may also be responsible for proofreading any medium that includes coverage of health and medical issues.
oin CHI-California Healthcare Institute, in collaboration with Merrill DataSite®, invite you to a complimentary, 75-minute webinar which will address the provisions of the Agency-industry negotiated agreement, potential additional and related provisions likely to be considered by Congress and what it all means for the biopharmaceutical industry.
