On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answers,”...more
11/6/2023
/ Comment Period ,
Communication Restrictions ,
Evidentiary Standards ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Public Comment ,
Scientific Evidence
The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. ...more
On Jan. 15, 2021, the U.S. Department of Health & Human Services (HHS) issued a notice, “Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From...more
The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and...more
In response to the COVID-19 outbreak in the United States, the Food and Drug Administration (FDA) has issued an increasing number of EUAs, now in the double digits, for in vitro diagnostic (IVD) products and personal...more
The U.S. now has the most confirmed coronavirus cases in the world, and the FDA and state boards of pharmacy are issuing daily guidance on how to stop the spread or join in the fight through relaxed standards or expedited...more
3/30/2020
/ Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Manufacturers ,
Medical Devices ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Pharmacies ,
Restaurant Industry ,
Veterinarians
Last week Health and Human Services (HHS) released its Statement of Regulatory Priorities for Fiscal Year 2019. Several of the FY19 priorities include: (1) combatting the opioid crisis; (2) strengthening individual health...more
Please join us for this complimentary CLE webinar.
With increasing healthcare costs and the transition to value-based reimbursement, never has the need for connected medical devices been so great – and never have the...more
The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more
6/22/2015
/ 21st Century Cures Initiative ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medicare ,
Medicare Part D ,
Pending Legislation ,
Pharmacies ,
Prescription Drug Coverage ,
Prescription Drugs ,
Trade Associations
The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more