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In a recently released podcast, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research ("CDER"), discussed how patient advocacy groups are playing a more significant role in the drug development process.

FDA's Center for Drug Evaluation and Research recently issued final guidance discussing the purpose, scope, and administrative procedures for critical path innovation meetings.

The notice invites industry, academia, and health care facilities to apply to participate in this formal training.

In the April 20, 2015, Federal Register, FDA's CDRH announced it is launching an electronic submissions database of labels and package inserts for listed home-use devices.

State House News is reporting that Treasurer Deb Goldberg has named former Bain and Company partner Steven Hoffman as Chair of the about-to-be-formed Cannabis Control Commission.

Rule 23(b)(3) Damages. In an action challenging The Salvation Army's policy at its adult rehabilitation centers that prevented individuals...

Mark L. Silow was featured in the Bloomberg Law article, "Clients Got This Big Law Firm Hooked on Marijuana."

On December 3, 2013, CMS will host a National Provider Call to provide an overview of the value-based payment modifier (VM) under the final 2014 Medicare Physician Fee Schedule final rule (which has not yet been released).

On February 14, 2019, CMS is hosting an educational call on new opioid policies for Medicare drug plans.

CMS and FDA are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs), which are tests intended for clinical use and designed, manufactured, and used within a single lab.

The Centers for Medicare & Medicaid Services (CMS) has issued a "payment advisory" alerting approximately 1,400 clinicians who are Qualifying APM

CMS invites participation by Medicare beneficiaries and advocacy groups, pharmacies, plan sponsors, pharmacy benefit managers, and other interested parties.

On October 1, 2015, the Centers for Medicare & Medicaid Services ("CMS"), the agency that administers the Open Payments program, posted the teaching hospital list and key (de minimus) thresholds for calendar year 2016 reporting.

The Centers for Medicare and Medicaid Services ("CMS") recently released three documents addressing payments for biosimilars under Medicare Parts B and D and Medicaid.

CMS has released the average sales price (ASP) files that will be used to pay for Medicare Part B drugs for the third quarter of 2014.

CMS has announced that the next meeting date of the Advisory Panel on Clinical Diagnostic Laboratory Tests will be September 12, 2016.

Last week, Democrats in both chambers of Congress introduced legislation banning bisphenol A ("BPA") from food packaging.

On December 18, 2015 ,Congress repealed the controversial U.S. Country-of-Origin-labeling rule, thereby avoiding the $1 billion in retaliatory tariffs from Canada and Mexico recently authorized by the World Trade Organization.