General Business Administrative Agency Health

Read need-to-know updates, commentary, and analysis on General Business issues written by leading professionals.
News & Analysis as of

Final Menu Labeling Rules Released by FDA

The U.S. Food and Drug Administration (FDA) released two final rules for menu and vending machine labeling on November 25, 2014. The long-awaited rules stem from provisions in the Affordable Care Act (ACA), the comprehensive...more

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing...more

Behavioral Managed Care Organizations Do Not Have Unbridled Discretion – Providers Have Rights

Here is a common scenario: A behavioral healthcare provider has committed substantial resources into developing specialized behavioral healthcare services in the counties managed by a Managed Care Organization (“MCO”) under...more

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE)...more

Focus on Regulatory Law - October 2014

In This Issue: - Regulatory Authorities - Energy - Public Economy Law - State Aid - Contract - Public Health - In Brief - Excerpt from Regulatory Authorities: French Competition...more

MoFo New York Tax Insights - Volume 5, Issue 9 - September 2014

In This Issue: - ALJ Upholds Denial of Sales Tax Refund Because Vendor Failed to First Make Refunds to Customers - HMO Held Exempt from New York City General Corporation Tax - State Tax Department Issues...more

ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review

As a manufacturer of generic drug products, undoubtedly one of your goals is to prepare an Abbreviated New Drug Application (ANDA) that will pass regulatory scrutiny efficiently. Your ANDA submission is a culmination of time,...more

Favorable Ruling: Taxability of HMOs Under New York City General Corporation Tax

A New York City Tax Appeals Tribunal Administrative Law Judge (ALJ) recently ruled in favor of Aetna, Inc. (Aetna) on whether a health maintenance organization (HMO) was “doing an insurance business” in New York State,...more

The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors

On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed consent process...more

Health Care Reform Implementation Update - July 2014

Last week the Senate debated a bill to reverse the Supreme Court’s contraception mandate decision, a group of House Republicans introduced a bill to replace Affordable Care Act (ACA) cuts to the Medicare home health benefit...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

FDA Finalizes Guidance on "Mobile Medical Applications"

On September 25, 2013, the Food and Drug Administration (FDA) issued final guidance on Mobile Medical Applications – healthcare related software applications intended for use on mobile platforms such as smartphones and...more

Court Sides With CMS Stark Regulations on Physician-Owned Under Arrangement Service Providers

On May 24, the U.S. District Court for the District of Columbia in Council for Urological Interests v. Sebelius1 (‘‘CUI’’) sided with the Centers for Medicare & Medicaid Services in a lawsuit brought by a group of urologists...more

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more

FDA Issues Final Rule Regarding CGMPs for Combination Products

On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more

OIG Advisory Opinion Sheds Light On Pay-For-Performance Relationships Between Hospitals And Physicians

On January 7, 2013, the HHS OIG released Advisory Opinion 12-22 concerning a rural hospital's (Hospital) proposal to pay a cardiology group (Group) a performance bonus for achieving certain patient service, quality and cost...more

FDA Announces Public Meeting to Discuss Standardization and Availability of Medical Device Labeling

On April 29-30, 2013, FDA will hold a public workshop to discuss standardizing the format and content of medical device labeling and the development of a public repository/database that would provide access to the labeling of...more

FDA Issues Final Guidance Documents on FDA’s eCopy Program for Medical Device Submissions

On December 31, 2012, FDA issued a final guidance document entitled “eCopy Program for Medical Device Submissions” (“eCopy guidance”). Section 745A(b) of the Federal Food, Drug, and Cosmetic (FDC) Act, which was added by...more

FDA Issues New Guidances Regarding Its Preliminary Review of 510(k) Notices and PMA Applications

On December 31, 2012, FDA issued two final guidances that replace prior guidances related to the review of premarket submissions: “Refuse to Accept Policies for 510(k)s” and “Acceptance and Filing Reviews for Premarket...more

FDA Issues Final Guidance on Filing PMAs and 510(k)s

On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled “Refuse to Accept Policy...more

Summary Of HUD’s New Draft LEAN Loan Documents, December 21, 2012

On September 7, 2012, the Federal Housing Administration (FHA) published new regulations for the Section 232 Healthcare Facility Insurance Program in the Federal Register. FHA had previously proposed new regulations and loan...more

Summary Of HUD’s LEAN 232 Program E-Mail Blast: Office Of Residential Care Facilities (ORCF), December 19, 2012

In an effort to summarize the highlights of the LEAN E-mail Blasts that we receive, and rarely have time to review in a timely fashion, we at Pepper are providing this quick synopsis of the latest LEAN update. Our aim is to...more

Insurance Antitrust Legal News - January 2013 • Volume 2, Number 1

In This Issue: - Michigan Governor Vetoes Legislation Banning Health Insurers From Utilizing Most Favored Nation Clauses In Provider Contracts - DOJ Antitrust Division Approves Wellpoint’s Acquisition Of...more

236 Results
|
View per page
Page: of 10

Follow General Business Updates on: