News & Analysis as of

Biologics Pharmacies

Health Care Compliance Association (HCCA)

CMS Hikes Payment for COVID-19 Inpatients Treated With New Drugs, Links it to 20% Bonus

Report on Medicare Compliance 29, no. 39 (November 2, 2020) - CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA)...more

Epstein Becker & Green

Current Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk...

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FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Update on Florida’s Canadian Prescription Drug Importation Program

This year, Florida Governor Ron DeSantis signed into law a bill that creates Florida Statute Section 381.02035, which establishes the Canadian Prescription Drug Importation Program within the Agency for Health Care...more

Akerman LLP - Health Law Rx

Florida Board of Pharmacy Initiates Work on International Export Pharmacy Permit Application and Rules

International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the...more

Smart & Biggar

Rx IP Update - February 2019

Smart & Biggar on

Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Holland & Knight LLP

New Proposed Medicare Part B Drug Reimbursement Model Raises Questions

Holland & Knight LLP on

• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals. • The proposed structure, called the International Pricing Index (IPI)...more

Hogan Lovells

CMS releases Medicare Advantage/Part D final rule

Hogan Lovells on

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released a final rule to revise regulations and clarify program requirements within the Medicare Advantage (MA) and the Prescription Drug Benefit (Part D)...more

Epstein Becker & Green

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2: Beneficiary...

On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more

Hogan Lovells

CMS Releases Major MA/Part D Proposed Rule

Hogan Lovells on

CMS released the first major MA/Part D rulemaking in several years, proposing a number of significant changes to the Part D program, including required pass-through of pharmaceutical company rebates to lower patient...more

Mintz - Health Care Viewpoints

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more

Goodwin

New Mexico Senate Passes Bill Allowing Automatic Substitution of Interchangeable Biologics

Goodwin on

Last week, the New Mexico Senate passed a bill that would amend New Mexico’s existing automatic substitution law for small molecule drugs to allow “a pharmacist to dispense any one of the … interchangeable biological products...more

McDermott Will & Emery

FDA 2016 Year in Review

McDermott Will & Emery on

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

Goodwin

Arizona Passes Biosimilar Automatic Substitution Law

Goodwin on

Last month, the governor of Arizona signed a bill into law allowing pharmacists to automatically substitute a biosimilar for a reference branded biologic. Arizona continues the recent trend of states enacting biosimilar...more

Mintz - Health Care Viewpoints

California Becomes Latest State to Pass Biosimilar Substitution Law

On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more

Akin Gump Strauss Hauer & Feld LLP

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

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