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Restaurant Franchisors: Prepare to Comply With New FDA Menu Labeling Rules

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

Blog: No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human...more

FDA Science Chief Reports Quicker Medical Device Clinical Trial Approvals

In a speech in Cambridge on December 11, 2014 (which was reported on in an article in the Boston Business Journal), Dr. Bill Maisel- the science chief of the U.S. Food and Drug Administration’s center to oversee approval of...more

Illinois Supreme Court Agrees to Decide Whether Pension Board's Disability Finding is Preclusive in Employee Benefits Act...

In the closing days of its November term, the Illinois Supreme Court agreed to decide whether a pension board’s finding that an officer is disabled for pension purposes is preclusive of the employer’s liability for health...more

FDA Issues Guidance on “Patient Counseling Information”

The Food and Drug Administration (FDA) has released new Guidance to assist in developing the “Patient Counseling Information” section of labeling required under § 201.57(c)(18) of the “Physician Labeling Rule.” See 21 C.F.R....more

The Future of MassHealth: Five Priority Issues for the New Administration

Executive Summary - The past decade marked an era of seismic change in the Massachusetts health care market and one in which the Commonwealth led the nation in coverage and delivery system reform. In 2006,...more

AHA Proposes Putting RACs on the Rack

The American Hospital Association formally proposed last week that Recovery Audit Contractors (RACs) be fined when their denials are overturned on appeal....more

FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities

On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include...more

Survey Says Sharing Information is Crucial in a Volatile Data Security Environment

Information sharing allows for better insight into existing threats and vulnerabilities and alerts organizations to the existence of important data that can help prevent cyberattacks and mitigate the effects of ongoing...more

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

HHS to Audit Hospital Reporting of GPO Payments: GAO Report Suggests Further Scrutiny of GPO Shareback with Hospitals

On November 24, 2014, the Government Accountability Office (“GAO”) published a report examining the contracting practices and funding structures of health care group purchasing organizations (“GPOs”) and their potential...more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

Health Alert (Australia) - December 8, 2014

In This Issue: Judgments and Reports. Excerpt from Reports: Australia. Department of Social Services - 4 December 2014 - 2014 Aged Care Approvals Round (ACAR) results. Senator Mitch Fifield,...more

Texas Appeals Court Invalidates Certain Medicaid Payment Hold Rules

Last week, a Texas appeals court invalidated three rules that permitted the Texas Health and Human Services Commission (HHSC) and the Texas OIG to impose a pre-notice payment hold against a Medicaid provider in certain...more

OMB Releases Fall 2014 Regulatory Agenda

The White House Office of Management and Budget’s Office of Information and Regulatory Affairs has released its semi-annual Unified Regulatory Agenda and Regulatory Plan for Fall 2014, covering more than 60 Federal...more

FDA Issues Much Anticipated Final Rules on Menu and Vending Machine Nutrition Labeling

The U.S. Food and Drug Administration (FDA) recently published the long awaited final rules on menu and vending machine nutrition labeling. The rules implement section 4205 of the Patient Protection and Affordable Care Act...more

Health Care Update - December 2014

In This Issue: - FDA Releases Menu Labeling Rule - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Upcoming Congressional Hearings - Excerpt from FDA...more

New Jersey Court Supports Peer Review Immunity for Hospital

On November 24, 2014, the New Jersey Appellate Division affirmed a lower court’s decision to dismiss a physician’s lawsuit against a hospital based on federal and state statutory immunity provisions that shield hospitals and...more

Case Comments: Interpretation of Standards of Practice and Standard of Review

Hunter v College of Physicians & Surgeons of Alberta, 2014 ABCA 262 (Alta CA), upholding the decision of the Council for the College and dismissing the appeal. A physician who married his former patient challenged his...more

FDA Updates Manual on Review of INDs Seeking Exception from Informed Consent for Emergency Research under 21 C.F.R. § 50.24

On November 17, 2014, the U.S. Food and Drug Administration (FDA) published a revised version of its internal review procedures and policies for Investigational New Drug applications (INDs) that implicate the exception to the...more

FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)

The U.S. Food and Drug Administration (FDA) recently published a report titled "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)," which summarizes stakeholder engagements completed in fiscal year...more

FDA Draft Guidance Clarifies Criteria and Process for Obtaining Rare Pediatric Disease Priority Review Vouchers

On November 17, 2014, the Food and Drug Administration (“FDA”) released a draft guidance entitled Rare Pediatric Disease Priority Review Vouchers, which describes an incentive program for the development of drugs intended to...more

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

Representative Brady Introduces Discussion Draft of the Hospital Improvements for Payment Act of 2014

On November 19, 2014, House Ways & Means Health Subcommittee Chairman Kevin Brady introduced a 146-page discussion draft of the Hospital Improvements for Payment Act of 2014 (HIP). HIP seeks to, among other things, make...more

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

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