article thumbnail

Monthly Round-Up of What to Read on Pharma Law and Policy 

Bill of Health

Dose modification rules and availability of growth factor support: A cross-sectional study of head-to-head cancer trials used for US FDA approval from 2009 to 2021. FDA validation of surrogate endpoints in oncology: 2005-2022. Eur J Cancer. 2022 Sep;172:349-356. Epub ahead of print. Walia A, Haslam A, Prasad V. J Cancer Policy.

FDA 241
article thumbnail

Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Anticancer Drugs Approved by the US Food and Drug Administration From 2009 to 2020 According to Their Mechanism of Action. A full posting of abstracts/summaries of these articles may be found on our? Barber M, Sarpatwari A, Cepuch C. COVID-19 antivirals must not affect HIV drug supply. 2021 Dec 3;374(6572):1205-1207. JAMA Netw Open.

COVID-19 176
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Tobacco Issues Awaiting Robert Califf at the FDA

Bill of Health

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes. Reviewing E-cigarettes.

FDA 274
article thumbnail

The Heart Health Continuum at #CES2023 – From Prevention and Monitoring to Healthy Eating and Sleep

Health Populi

. “Despite breathtaking medical advancements since President Harry Truman declared war on heart disease 75 years ago, researchers have observed a disturbing trend that started in 2009: America’s death rate from heart-related conditions is climbing again,” the detailed essay explains.

FDA 104
article thumbnail

Cybersecurity is Now a Patient Safety Issue, Suggests Sen. Warner In Congressional Report

HIPAA Journal

The Department of Health and Human Services (HHS) is the Sector Risk Management Agency (SRMA) for the healthcare industry, but within the HHS agencies such as the Office for Civil Rights (OCR), Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA) have their own jurisdictions and cybersecurity policies.

HIPAA 121
article thumbnail

Digital Documentation: How PDFs Can Help Providers Expedite Care

HIT Consultant

The transition toward more digital recordkeeping in healthcare began in earnest in 2009 with the passage of the American Recovery and Reinvestment Act. If this documentation is primarily paper-based, researchers could have a difficult time ensuring each piece of documentation meets FDA standards.

FDA 98
article thumbnail

Uber Health Hires First Chief Medical Officer, Aledade’s New CEO, Other Digital Health Appointments

HIT Consultant

Big Health , a digital therapeutics company dedicated to helping millions back to good mental health, today announced that it has added former Food and Drug Administration (FDA) Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah to its Board of Directors.