Manufacturers

News & Analysis as of

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

Hot Topics in Supply Chain Compliance

The last few years have seen a proliferation of new supply chain-focused regulations and other compliance obligations, a trend which isn’t likely to abate any time soon. In this Alert, we provide an overview of selected...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

France tightens grip on industry payments to HCPs (again)

On 19 January 2017, major modifications were adopted in France to the regulations on interactions between the industry and healthcare professionals (and other stakeholders). These new regulations, a.k.a. "anti-benefits...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

CPSC Recall Snapshot: January 2017

Welcome to the January edition of the Alston & Bird CPSC Recall Snapshot. December was a relatively quiet month for the CPSC, but major changes are most likely in store for 2017. If tradition holds true, Chairman Elliot...more

EPA Publishes New TSCA Framework Rules

The revised Toxic Substances Control Act (TSCA) was enacted in June 2016. TSCA requires the U.S. Environmental Protection Agency (EPA) to finalize several “framework” rules by June 2017. Recently, EPA published three of these...more

Going After A Hospital For Off-Label Use Of A Device

It seems that we have posted hundreds of times about attempts to impose liability on the manufacturer of a PMA device that a doctor chose to use off-label. Recently, a bunch of those have involved Infuse. Cales v. Baptist...more

FDA Issues Draft Guidance Addressing Communications with Payors

On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more

Manufacturing Law Predictions for 2017:  Labor and Employment

As has been our tradition, January is the time to predict the big developments in the coming year which will impact on manufacturers. Notwithstanding my “Lawyer’s Shrug,” here is my take on 2017....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

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...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

President Trump, the Ex-Im Bank and Aircraft Finance

The Export-Import Bank of the United States has been embroiled in a considerable amount of political controversy in recent years. Created in 1934 by a presidential executive order to finance and facilitate the export of U.S....more

FDA Recommends Maximum Level of Lead in Cosmetic Products . . . But Finds that Most Products Surveyed are Already Well Below the...

As 2016 comes to an end, the Food and Drug Administration (FDA or agency) is turning its attention to cosmetics by issuing a draft guidance on December 21, 2016 recommending a limit of “no more than 10 parts per million (ppm)...more

A Case Study on How Regional Manufacturing Firms Are Increasingly the Targets of Cybercrime

As their methods evolve, cybercriminals are increasingly targeting regional manufacturing businesses with sophisticated and potentially costly attacks. A recent ransomware attack on a mid-sized manufacturer in the Southeast...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

TSCA: EPA Releases Proposed Chemical Risk Evaluation Process Under New TSCA

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) proposed a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or 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

EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA

The U.S. Environmental Protection Agency (EPA) proposed on January 17, 2017, procedures to establish the risk-based screening process and criteria that EPA will use to identify chemical substances under the Toxic Substances...more

340B Update: HRSA Finalizes 340B Pricing & Penalties for Drug Manufacturers

On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...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

Plaintiffs Have Come Up Empty on Class Action Slack Fill Litigation But Are Expected to Pick It Up in 2017

Complaints regarding the amount of product contained in a particular package appear to be the new battlefront on which plaintiffs are waging war on a wide range of consumer product manufacturers. The lawsuits are spurred by a...more

New Jersey District Court Finds Products and Workmanship Exclusions Ambiguous

The United States District Court for the District of New Jersey closed out 2016 with a declaration that the Products and Workmanship exclusions found in a manufacturer’s Building and Personal Property policy is ambiguous. In...more

FDA bans powdered gloves in human, animal medicine

Effective Jan. 18, 2017, the federal Food and Drug Administration has, by implementation of a final rule, banned the use of powdered gloves by a physician when treating humans or animals. Powdered gloves are now added to the...more

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