Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Holland & Knight ordered by Published Date Descending.
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Healthcare Law Update: October 2019
The FDA's patient engagement efforts are continuing.
United States
22 Oct 2019
New Medicare Part D Demonstration To Address Proposed Changes To Anti-Kickback Safe Harbors
The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D demonstration to address the potential
United States
26 Apr 2019
Senate Finance Committee Begins Review Of Nonprofit Hospitals
Senate Finance Committee Chairman Charles Grassley (R-Iowa) has launched a new review of nonprofit hospitals, continuing a longstanding oversight in the sector.
United States
5 Mar 2019
FDA Issues Warning Letter Regarding Unapproved Stem Cell Products
The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products.
United States
3 Jan 2019
FDA's 510(K) Modernization Efforts — Safety And Performance Based Pathway
On Nov. 26, 2018, the U.S. Food and Drug Administration (FDA) Commissioner and Director for the Center for Devices and Radiological Health (CDRH) announced FDA's plan to "modernize the FDA's 510(k)
United States
28 Dec 2018
FDA Commissioner Speaks Out On Compliance And Enforcement
FDA Commissioner Speaks Out On Compliance And Enforcement
United States
19 Dec 2018
Left To Their Own Devices: Administration, FDA Turn To Medical Device Innovation
Masked by the recent high-profile drug pricing debate has been the Trump Administration's discussions about the development, approval and reimbursement of medical devices
United States
1 Nov 2018
Healthcare Law Update: May 2018
On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 18-02 regarding the provision of sample ostomy products...
United States
30 May 2018
Congress Continues Push On Medical Device Cybersecurity Mandates
FDA Issues Medical Device Safety Action Plan; DHS Continues to Issue Vulnerability Alerts
United States
23 May 2018
FTC Announces Revised Hart-Scott-Rodino Thresholds For Acquisitions And Exclusive Licenses
In addition to increases in the HSR thresholds, there are also increases in the filing fee tier levels and possible civil penalty amounts
United States
2 Feb 2018
Digital Health: FDA Issues Long-Awaited Draft Guidance On Clinical Decision Support Technology
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology.
United States
12 Dec 2017
Second CAR-T Cell Therapy Approved By FDA
Less than two months after approving the first gene therapy for use in the U.S., that of Novartis's Kymriah for treatment of pediatric patients with acute lymphoblastic leukemia (ALL)...
United States
31 Oct 2017
Healthcare Legislation Outlook And Update
In this memorandum, Holland & Knight's Healthcare & Life Sciences Team summarizes recent U.S. Senate action on healthcare legislation and provides an outlook on upcoming issues and possible actions.
United States
16 Aug 2017
FDA Announces New Initiatives To Regulate Digital Health Technologies
FDA Commissioner Scott Gottlieb, MD, posted a blog today announcing new FDA initiatives re: regulation of digital health technologies to be piloted this fall.
United States
26 Jun 2017
Healthcare IT News: OIG Does An About-Face On Referral Service Pricing
On April 8, 2014, the Department of Health and Human Services Office of Inspector General took the unusual step of terminating a favorable advisory opinion it had issued in November 2011 regarding a healthcare IT company's "per-click" pricing model for its provider referral management software.
United States
17 Apr 2014
CMS Issues Medicare Advantage And Part D Final Call Letter For 2015
On April 7, 2014, the Centers for Medicare and Medicaid Services (CMS) released its Medicare Part C and Part D Final Call Letter. - See more at:
United States
16 Apr 2014
New HIPAA Settlement And Leadership Changes At OCR
The Department of Health and Human Services (HHS), on December 26, 2013, announced a settlement with Adult & Pediatric Dermatology, P.C., a dermatology practice in Concord, Massachusetts. This settlement, which resulted from an HHS Office for Civil Rights (OCR) investigation, illustrates the importance of a thorough HIPAA compliance program. It also shows that settlements may take years to negotiate. The matter began on September 14, 2011 when an unencrypted thumb drive was stolen from an unatte
United States
2 Jan 2014
Drug Quality And Security Act Gives FDA Authority To Regulate Drug Compounding And Creates Uniform Federal Standards For Distribution
On Nov.18, Congress enacted sweeping changes to the laws governing the safety of the drug supply.
United States
19 Nov 2013
CMS Issues Final Rule On Medical Loss Ratio For Medicare Advantage And Part D
CMS recently issued its Final Rule on Medical Loss Ratio requirements for Medicare Advantage and Medicare Part D programs.
United States
11 Jun 2013
Is Filling An Off-Label Prescription An Invitation To False Claims Act Liability?
On May 17, 2013, the U.S. District Court for the Northern District of Georgia issued an order that joins an unsettling line of decisions.
United States
8 Jun 2013
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