Pharmaceutical Industry Manufacturers

News & Analysis as of

What Is “Product Liability”?

We’re serious – we’re not planning to give a flip answer like “an extortion racket.” No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?” (Hint – that’s discussed...more

Form Drug Distribution Services Agreements May Not Be Formulaic

Vanilla-looking form agreements may contain or omit terms that are important to one or both parties. We were recently reminded of the danger of entering into form pharmaceutical distribution services agreements. Although...more

International Product Liability Review - Issue 65

The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. Please see full Publication below for more...more

Market Watch – Arven Pharmaceuticals Bulks Up with GE Healthcare’s FlexFactory

According to a press release from GE Healthcare, Arven Pharmaceuticals, a Turkish pharmaceutical company, has selected GE Healthcare’s FlexFactory platform to increase its manufacturing capacity. GE describes FlexFactory as a...more

Product Liability Update: January 2017

Massachusetts Appeals Court Holds Birth Control Patch Manufacturer Had Duty to Warn Patient Directly But Packet Insert Adequately Warned of Greater Risk of Blood Clots As Compared to Birth Control Pill; Design Defect Claim...more

Blog: Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting...

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access...more

France imposes an extra notification obligation on Class III and implantable medical devices manufacturers

On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“French Law 2016-41”) was adopted. This Decree provides important information concerning the...more

FDA Issues Draft Guidance on Payor Communications

Shortly after the recently enacted, bipartisan 21st Century Cures Act, which revised and expanded the extent to which specific health care economic information (HCEI) may be disseminated to certain stakeholders, and comes...more

Top Ten International Anti-Corruption Developments for December 2016

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at...more

FDA Issues Draft Guidance on Communications That Are Consistent with FDA-Required Labeling

This On the Subject reviews the US Food and Drug Administration’s recently released draft guidance on promotional materials and communications that are consistent with FDA-required labeling. The guidance provides a...more

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

Current good manufacturing practice requirements for combination products

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

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

Expanded Requirements for Expanded Access: The 21st Century Cures Act Places New Requirements on Manufacturers and Distributors

The 21st Century Cures Act (Cures Act) makes a number of changes affecting the pharmaceutical and biologics industries, and AGG previously has written on some of these changes. This update will focus on how the Cures Act...more

21st Century Cures: A Closer Look

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

UK MHRA to develop quality standards for biological medicines

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

Obama Administration Issues Changes to Iran Sanctions Regulations That Benefit Exporters of Medicine, Medical Devices and...

On December 23, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) published a number of changes to the Iranian Transactions and Sanctions Regulations (“ITSR,” 31 C.F.R. Part 560) that expanded the...more

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ? Intent, But Knowledge Certainly Can Be One Element in Establishing the...

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

HRSA Announces Final Rule on Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B...more

Final Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more

Happy Holidays from FDA: The Agency Issues Four Enforcement Letters for Unlawful Promotion

The Food and Drug Administration recently issued holiday gifts, in the form of enforcement letters, to four pharmaceutical companies. The letters are reminders that FDA is not in a partying mood when it comes to unlawful...more

UK MHRA publishes “top tips” for manufacturing authorisation applicants

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce...more

Final Rule for Penalties Relating to 340B Drug Pricing Program Nears Release

On December 23, 2016, the White House Office of Management and Budget (OMB) completed review of a final rule for penalties under the 340B Drug Pricing Program for drug manufacturers that intentionally charge a 340B covered...more

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