News & Analysis as of

Biologics Manufacturers

A Path Forward: Corporate Integrity Agreement Sheds Light on Manufacturer Interactions With Independent Charitable Foundations

by Hogan Lovells on

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

by Baker Ober Health Law on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

To the Spoiler Go the Spoils: OIG Approves Limited Product Replacement Program

by Hogan Lovells on

A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle circumstances in which the product is spoiled, breaks, or otherwise becomes...more

Health Care Provider Insights - Introductory Edition

by Wilson Elser on

Welcome to the introductory edition of Health Care Provider Insights. We are practice management consultants, providing legal and business management advice and assistance to physicians and dentists (health care...more

A&B Healthcare Week in Review

by Alston & Bird on

On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

Current good manufacturing practice requirements for combination products

by Hogan Lovells on

On January 11, 2017, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled “Current Good Manufacturing Practice Requirements for Combination Products.”[1] This guidance describes and explains...more

UK MHRA to develop quality standards for biological medicines

by Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines....more

FDA Call For Comments on Off-Label Communications

by Goodwin on

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications...more

FDA Issues Final Rule on Use of Symbols in Labeling

by Knobbe Martens on

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

Connecticut's New "Right to Try" Law Provides Hope for Patients and Providers, but FDA Remains in the Driver's Seat

by Shipman & Goodwin LLP on

Connecticut has recently joined the wave of states enacting a so-called “Right to Try” law, which ostensibly permits terminally ill patients access to investigational drugs (including biologics) and medical devices as a...more

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

by Cozen O'Connor on

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more

FDA Biosimilars Guidance Not Conducive To Preemption

by Reed Smith on

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...more

CMS Publishes Final Sunshine Act Rule

This afternoon, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule (Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act). The Sunshine Act requires manufacturers of...more

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