Searching Content indexed under Healthcare by Frederick Ball ordered by Published Date Descending.
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AdvaMed's Updated Code Of Ethics
The Advanced Medical Technology Association (AdvaMed) has published its updated Code of Ethics. The updated code will become effective on January 1, 2020. AdvaMed has also published an overview of changes.
United States
26 Feb 2019
DOJ Implements 2018 Granston Memo On False Claims Act
In early 2018, the U.S. Department of Justice announced a new policy encouraging prosecutors handling False Claims Act (FCA) ...
United States
10 Jan 2019
SUPPORT Act Expands Sunshine Act Disclosure Requirements, Covered Recipients
One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.
United States
26 Oct 2018
SUPPORT Act Expands Sunshine Act Disclosure Requirements
On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), ..
United States
25 Oct 2018
FDA Report On Standardizing And Evaluating Risk Evaluation And Mitigation Strategies (REMS)
The U.S. Food and Drug Administration recently published a report titled "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)".
United States
2 Dec 2014
CMS Lets The Sun Shine Down
As part of a growing movement on the State and Federal levels to shed light on potential conflicts of interest that may affect health care providers' treatment decisions, the Centers for Medicare & Medicaid Services ("CMS") recently issued final rules detailing the reporting requirements under the Physician Payments Sunshine Act ("Sunshine Act").
United States
2 Jul 2013
Research-Related Payments And The Physician Payment Sunshine Act: How Reporting Works And What Applicable Manufacturers Should Consider
The Sunshine Act and Rules require applicable manufacturers to report research-related payments or other transfers of value that are ultimately made, in whole or in part, to covered recipients.
United States
12 Mar 2013
CMS Publishes Physician Payment Sunshine Rules; Manufacturers And Group Purchasing Organizations Are Required to Submit Detailed Annual Reports
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the Affordable Care Act, otherwise known as the Physician Payment Sunshine Act (the "Act").
United States
4 Mar 2013
U.S. Government’s Use Of The "Park Doctrine" To Police Pharmacies
Based on the current public scrutiny that compounding pharmacies are under due to the outbreak of fungal meningitis in Massachusetts, pharmacy executives may want to review their internal procedures for compliance with the FDCA to ensure they are robust.
United States
8 Jan 2013
D.C. Circuit Affirms HHS Power To Disqualify Corporate Officials Convicted Of Misdemeanors Under The "Responsible Corporate Official" (RCO) Doctrine
On July 27, 2012, the U.S. Court of Appeals for the D.C. Circuit issued the long-anticipated decision in Friedman v. Sebelius.
United States
14 Aug 2012
OIG For HHS Publishes Solicitation Of Information And Recommendations For Revising Its Provider Self-Disclosure Protocol
On June 18, 2012, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) published a solicitation for information and recommendations.
United States
30 Jun 2012
FDA Issues Draft Guidance on Affordable Care Act Prescription Drug Sample Transparency Program: Reporting Deadline Informally Extended to October 1, 2012
Until at least October 1, 2012, the FDA does not intend to object if manufacturers and authorized distributors of record do not submit the information required under the prescription drug sample transparency program.
United States
13 Apr 2012
Centers For Medicare And Medicaid Services Releases Proposed Rule On Reporting And Returning Of Overpayments
The U.S. Centers for Medicare and Medicaid Services (CMS) released a long-anticipated proposed rule on reporting and returning of overpayments on February 16, 2012.
United States
14 Mar 2012
FDA Issues Draft Guidance For Notification Of Issues That May Result In Prescription Drug Shortage
On February 27, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance encouraging manufacturers of prescription drug and biologic products to voluntarily notify FDA of issues that may result in a shortage of the product in the U.S. market or potential disruption in the supply.
United States
7 Mar 2012
FDA Issues Proposed Rule Regarding Citizen Petitions And PSAs Related To Section 505(b)(2) Applications Or ANDAs
As part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) enacted on September 27, 2007, Congress added Section 505(q) to the federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 355(q)).
United States
10 Jan 2012
FTC Steps Up Enforcement On Health-Related Claims In Advertising
In a recent settlement with Reebok, the U.S. Federal Trade Commission (FTC) clarified that it will impose substantial penalties, including restitution to consumers, on companies that make health-related claims without an adequate basis.
United States
2 Nov 2011
New FDA Guidance For Industry On Implementation Of Fee Provisions Of The Food Safety Modernization Act
On October 6, 2011, the U.S. Food and Drug Administration (FDA) announced in the Federal Register its issuance of a question-and-answer guidance document related to the implementation of the fee provisions of the Food Safety Modernization Act of 2011 (FSMA).
United States
16 Oct 2011
FDA Publishes Final Guidance For Industry On Applications For Nonprescription Drug Products
The U.S. Food and Drug Administration (FDA) recently released a guidance on "Time and Extent Applications for Nonprescription Drug Products" (the "Guidance").
United States
10 Oct 2011
FDA Issues Compliance Policy Guide That Provides Potential Business Advantage For Filing New Drug Application For Marketed, Unapproved Drug
On September 19, 2011, the U.S. Food and Drug Administration (FDA) issued a Compliance Policy Guide (CPG) titled "Marketed Unapproved Drugs," which revises the FDA's 2006 CPG regarding the same topic.
United States
6 Oct 2011
U.S. District Judge Rejects FDA's Attempted Regulatory Authority Over Compounding Pharmacies In United States v. Franck's Lab, Inc.
On September 12, 2011, the U.S. District Court for the Middle District of Florida in United States v. Franck's Lab, Inc. denied a request by the U.S. Food and Drug Administration ("FDA") for an injunction and summary judgment against a compounding pharmacy.
United States
26 Sep 2011
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