Mega Budget Bill Boosts Funding for Biomedical Research, FDA programs

After months of delay, Congress finally passed a $1.3 trillion omnibus budget bill March 22, 2018, just in time to avoid another government shut-down. The measure increases federal support for biomedical research and health programs for fiscal year 2018, which began months ago. A m Powered by WPeMatico Continue reading Mega Budget Bill Boosts Funding for Biomedical Research, FDA programs

FDA s Gottlieb Hits Innovators, Insurers for Blocking Biosimilar Uptake

Pernicious rebating and contracting schemes and Kabuki drug-pricing constructs expose consumers to high out-of-pocket costs for biosimilars and actively discourage competition from these more affordable alternatives, says FDA commissioner Scott Gottlieb. As part of FDA initiatives to reward Powered by WPeMatico Continue reading FDA s Gottlieb Hits Innovators, Insurers for Blocking Biosimilar Uptake

Why a Data Health Check May Be the Best Medicine for Pharmaceutical Regulatory Compliance

Darren Cooper The way medicines are discovered and developed is changing, and regulatory organizations around the world, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are working on alignment schemes to create Identification of Medicinal Pr Powered by WPeMatico Continue reading Why a Data Health Check May Be the Best Medicine for Pharmaceutical Regulatory Compliance

Why a Data Heath Check May Be the Best Medicine for Pharmaceutical Regulatory Compliance

Darren Cooper The way medicines are discovered and developed is changing, and regulatory organizations around the world, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are working on alignment schemes to create Identification of Medicinal Pr Powered by WPeMatico Continue reading Why a Data Heath Check May Be the Best Medicine for Pharmaceutical Regulatory Compliance

Trump Budget Boosts FDA, Squeezes Resources for NIH & Healthcare

FDA advocates on all sides applauded the request to increase funding significantly for FDA under the Trump administration s budget for fiscal year 2019, which seeks more than $400 million in additional outlays for oversight of drugs, biologics and medical devices. The Alliance for a Stronger FDA Powered by WPeMatico Continue reading Trump Budget Boosts FDA, Squeezes Resources for NIH & Healthcare

Gottlieb To Promote Biosimilars, Safer Opioid Packaging

In highlighting key FDA priorities for the coming months, commissioner Scott Gottlieb told agency advocates in Washington D.C. that he will continue to seek ways to curb rampant opioid addiction, to promote competition that curbs high drug prices, and to advise on right-to-try legislation that h Powered by WPeMatico Continue reading Gottlieb To Promote Biosimilars, Safer Opioid Packaging

More New Drugs and Generics Reshape Pharma Markets

Amidst all the outrage over surging pharma prices, the continued growth in generic drug prescribing has moderated overall spending on medicines, cooling the political heat on industry. Generics now account for nearly 90% of prescription drug use in the US due to policies facilitating their devel Powered by WPeMatico Continue reading More New Drugs and Generics Reshape Pharma Markets