The U.S. Food & Drug Administration (FDA) recently issued a discussion paper to gather feedback that will inform future policies and guidance regarding 3D printing medical devices at the point of care.
Amidst COVID-19...more
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule,...more
On November 15, 2021, the U.S. Department of Health and Human Services (HHS) announced the withdrawal of the policy established during the previous administration that limited U.S. Food and Drug Administration’s (FDA) ability...more
Recently, the U.S. Food and Drug Administration (FDA) notified several pharmaceutical companies that they must repeat their clinical and bioanalytical studies conducted by Synchron Research Services (Synchron) or Panexcell...more
In response to President Biden’s Executive Order on Promoting Competition in the American Economy—which called for the Secretary of Health and Human Services to publish for notice and comment a proposed rule on...more
On April 27, 2021, the U.S. Food and Drug Administration (FDA) sent a notice of noncompliance to Acceleron Pharma (Acceleron), accusing the company of failing to post clinical trial summary results on its cancer combination...more
What You Need to Know: On December 18, 2020, the Food and Drug Administration issued the second emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 18 years of age and older. Under...more
On August 20, 2020, the Department of Health & Human Services (HHS) released a statement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, which announced that...more
As the U.S. continues to struggle to make COVID-19 tests available for symptomatic and asymptomatic individuals, FDA’s position regarding COVID-19 test standards is evolving. The FDA’s pivot is possibly a response to...more
The difficulties in accessing laboratory testing and securing prompt results present continuing challenges in the fight to control COVID-19. With scarce availability, there have been some attempts to limit tests to, or...more
On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more
Blockchain technology originated in 1991, and was conceived as a secure way to timestamp digital documents akin to how a notary timestamps physical documents. The true value lies in the fact that once stamped, the document...more
7/18/2019
/ Blockchain ,
Credentialing ,
Distributed Ledger Technology (DLT) ,
DSCSA ,
EHR ,
Electronic Medical Records ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Smart Contracts ,
Supply Chain ,
Technology
In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
3/6/2018
/ Anti-Kickback Statute ,
Attorney General ,
CGMP ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Misleading Statements ,
Off-Label Promotion ,
Opioid ,
Pharmaceutical Industry ,
REMS