News & Analysis as of

Manufacturers

July FCC Meeting Recap: Wireless Microphones Order on Recon and Further Notice: A Mixed Bag for Manufacturers and Users

by Kelley Drye & Warren LLP on

On July 13, 2017, the Federal Communications Commission (“FCC” or the “Commission”) revisited the regulatory framework applicable to wireless microphones in several important ways. The Order on Reconsideration addressed...more

Numerous Changes Are Coming Soon to the Federal Communications Commission’s Equipment Authorization and Importation Rules

by Kelley Drye & Warren LLP on

In a long-awaited decision, the FCC, at its July 13, 2017, Open Meeting acted to update its equipment authorization procedures and rules in a number of significant ways that manufacturers, importers, retailers, and others in...more

July 2017 FCC Meeting Recap: FCC Adopts Major Changes to Approval Procedures for Many RF Devices, E-Labeling, Importation...

by Kelley Drye & Warren LLP on

The Federal Communications Commission (“FCC” or “Commission”), at its July 13, 2017, Open Meeting updated its equipment authorization procedures and rules in a number of ways that will be of great interest to everyone in the...more

EU & Competition Update: Developments in regulating e-commerce, a quick tour of the European Commission’s final report (Dutch)

by Dentons on

In order to make the EU’s single market fit for the contemporary digital age, the European Commission adopted in 2015 the ‘digital single market strategy’. One of the three pillars of this strategy is to achieve better access...more

EU & Competition Update: Developments in regulating e-commerce, a quick tour of the European Commission’s final report

by Dentons on

In order to make the EU’s single market fit for the contemporary digital age, the European Commission adopted in 2015 the ‘digital single market strategy’. One of the three pillars of this strategy is to achieve better access...more

CPSC Recall Snapshot - Annual Report

by Alston & Bird on

Welcome to the July edition of the Alston & Bird CPSC Recall Snapshot. Last month, the CPSC released its 2016 Annual Report. The Annual Report was divided among five key strategies: (1) hazard identification and...more

FTC Warns 11 Companies Over Made in USA Claims

by Reed Smith on

It seems to be another star-spangled banner year for the Federal Trade Commission (“FTC”) and its crackdown on certain “Made in USA” claims. In 2016, the FTC cited 29 companies for their misleading “Made in USA” claims. With...more

New Maine Law Limits Manufacturer and Wholesaler Interactions with Health Care Professionals

by McDermott Will & Emery on

Maine recently amended its Pharmacy Practice Act to prevent licensed manufacturers or wholesalers and their agents from offering or giving certain gifts to practitioners. The bill’s sponsor tied the issue of gifts from...more

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

Settling the Discoverability of Settlement Agreements

by McDermott Will & Emery on

Settlement agreement between a co-defendant and plaintiff in a Hatch-Waxman patent litigation matter is discoverable, ruled Judge Bryson in Allergan, Inc. v. Teva Pharmaceuticals, Inc. et al., Case No. 15-1455 (E.D. Tex.,...more

The False Claims Act: Why It Is Relevant To All Manufacturers

The False Claims Act (FCA) is a major civil enforcement tool used by the federal government to redress fraud causing monetary loss to the government. In the 2016 fiscal year, the federal government recovered over $4.7...more

FCC Reforms its Equipment Approval Processes, Easing Burden on Device Manufacturers

by Davis Wright Tremaine LLP on

Last Thursday, the FCC reformed its equipment approval rules, which Commissioner Clyburn described as the first “comprehensive” review of these rules since 1998, although the rules remain complex and challenged by the fast...more

China's OEM jurisprudence 1.5 years after the Pretul case: OEM use may still infringe upon Chinese trademarks

by Hogan Lovells on

OEM is a business model whereby a trademark owner orders its products from a manufacturer, often located abroad, who manufactures and supplies products branded with the purchasers marks instead of his own marks. In China,...more

At the One-Year Mark, the EPA’s Existing Chemical Review Process is Taking Shape: What Does That Mean for Your Business?

On Thursday, June 22, 2017, the Environmental Protection Agency (EPA) announced a series of actions implementing its new authority to review the safety of chemicals already in U.S. commerce under the recently amended Toxic...more

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

China Updates New Industry Catalogue - PRC reduces regulatory procedures for foreign investments following its 2016 reforms

On June 28, 2017, the National Development and Reform Commission (NDRC) and the Ministry of Commerce (MOFCOM) of the People’s Republic of China (China) promulgated the 7th updated version of the Catalogue of Industries for...more

Blog: Off-Label Use Gets Congressional Hearing

by Cooley LLP on

Today, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug...more

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

Reversal of $48 Million Product Liability Verdict Required Due to Inconsistent Jury Findings on Failure to Warn Claims and...

In Trejo v. Johnson & Johnson, et al. (No. B238339, filed 6/30/2017), the California Second Appellate District held, among other things, that the jury’s finding that defendant was liable for negligent failure to warn was...more

Refrigeration Systems Targeted: Risk Management Plans and Release Reporting

by Williams Mullen on

Companies operating ammonia refrigeration systems are easy targets for EPA under a number of environmental programs. Recent history suggests release reporting under Section 112(r) of the Clean Air Act (CAA) and under the...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

FTC Submits Comments on Security Support for IoT Devices

by Reed Smith on

The Federal Trade Commission in June submitted comments to the working group convened by the U.S. Department of Commerce’s National Telecommunications and Information Administration (NTIA), which is studying the security of...more

Energy Independence in the Age of Renewables

by Foley & Lardner LLP on

Facing the traditional energy sector’s uncertain future and the decreased cost of producing renewable energy, many companies have taken to generating their own power. Manufacturers may be in an ideal position to do the same...more

R&D Based Domestic Industry Questions Remain

by Jones Day on

As noted in a previous post, ALJ Lord issued a domestic industry ruling, which the Commission later vacated without position, finding that R&D-based investments in plant and equipment or labor and capital cannot count towards...more

Protecting Your Manufacturing Innovations from Foreign Competition

by Ward and Smith, P.A. on

Commercial necessity often dictates that even though an innovation in the manufacturing process for a product occurs in the United States, the product may actually be made overseas and then sent to the United States for sale....more

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