Manufacturers

News & Analysis as of

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comes to an end, the Food and Drug Administration (FDA or agency) is turning its attention to cosmetics by issuing a draft guidance on December 21, 2016 recommending a limit of “no more than 10 parts per million (ppm)...more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

EPA's First Regulation of Nanomaterials May Impact Supply Chains

On January 12, 2017, the U.S. Environmental Protection Agency (EPA) issued a controversial rule requiring all persons who propose to commence manufacturing or processing certain nanoscale materials, or who have done so in the...more

TSCA: EPA Proposes Requirements for TSCA Inventory Notification (Active-Inactive)

On January 13, 2017, the U.S. Environmental Protection Agency (EPA) published a proposed rule that would require an electronic notification for chemical substances listed on the Toxic Substances Control Act (TSCA) Inventory...more

FDA Finalizes Guidance on Postmarket Management of Medical Device Cybersecurity

On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices. The guidance outlines nonbinding recommendations on how device manufacturers...more

Controlling L. mono in RTE Foods: FDA Publishes Draft Guidance

Quick Bite: The FDA is seeking comment until July 17, 2017, on draft guidance about recommended practices to control Listeria monocytogenes in food facilities. The Details: The Food and Drug Administration (“FDA”)...more

TSCA: EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a)

In an expected action, on January 11, 2017, the Administrator of the U.S. Environmental Protection Agency (EPA) signed a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to regulate the use of...more

Trade & Manufacturing - News of Note - January 2017

Customs and Border Protection Issues Update On Enforcement Of Trade Orders - U.S. Customs and Border Protection (CBP) released its AD/CVD Update for June/July 2016. As explained in the January 2015 and the August 2016...more

The Road to Recall: Evaluating Defects for Substantial Product Hazard

The U.S. Consumer Product Safety Commission (CPSC or the Commission) is the regulatory agency responsible for protecting the public from unreasonable risks of injury and death associated with consumer products. Pursuant to...more

Things Manufacturers Should Be Watching In 2017 In The Areas of Corporate Compliance / Litigation

As is our annual tradition, this is the first in a series of posts that provide industry and legal outlooks for manufacturers as we head into 2017. I will start with corporate compliance and litigation. Matt will follow...more

Rail Issues Before the New Administration

There was a plenty of rail-related activity during the 114th Congress and the last two years of the Obama Administration. Amtrak and the Surface Transportation Board (STB) were reauthorized with major changes to Amtrak's...more

Boozelaw: TTB Adopts Changes Designed to Benefit Startup Brewers, Winemakers and Distillers

For certain brewers, wine makers and distillers, the gift-giving season did not necessarily end in December. The Alcohol and Tobacco Tax and Trade Bureau (TTB) recently announced it has adopted changes that may impact the tax...more

FTC Goes After IoT Device Manufacturer for Alleged Security Vulnerabilities in Routers, IP Cameras

On January 6, the Federal Trade Commission (FTC) announced that it had filed a complaint against Taiwanese D-Link Corp. and its U.S. subsidiary, D-Link Systems Inc. (D-Link), alleging the company made deceptive claims about...more

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