News & Analysis as of

Manufacturers Regulatory Oversight Regulatory Requirements

Thomas Fox - Compliance Evangelist

Boeing: Accept the Omnibus Monitor Approach

I recently wrote a series of blog posts and articles on why the Department of Justice (DOJ) should think big and go big with a completely new approach to the monitorship for Boeing under its agreement to take a guilty plea....more

Arnall Golden Gregory LLP

Harmony and Me: FDA Issues Final Rule to Amend Quality System Regulation for Medical Devices

In 1973, Sir Elton John sang, “Harmony and me, we’re pretty good company,” on his classic album, Goodbye Yellow Brick Road. More than 50 years later, the Food and Drug Administration issued a Final Rule to amend the medical...more

Troutman Pepper

ENDS Companies Take Legal Action Against Allegedly Noncompliant Competitors

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Recently, NJOY LLC filed a complaint in the U.S. District Court for the Central District of California against more than 30 foreign and domestic defendants that manufacture, market, distribute, and sell tobacco products in an...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

Quarles & Brady LLP on

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Seyfarth Shaw LLP

Regulators Unveil Guidance On Best Practices for Internet Vehicle Sales

Seyfarth Shaw LLP on

Acknowledging that “[c]onsumers are clamoring for the opportunity to purchase the vehicles of their choice online because it expands the options available and enables them to save a considerable amount of time and possibly...more

Hogan Lovells

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

Hogan Lovells on

On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. ...more

McDermott Will & Emery

To Market, To Market: FDA’s Digital Health Precertification Program

McDermott Will & Emery on

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

Hogan Lovells

EU SPC Manufacturing Waiver Now in Force

Hogan Lovells on

The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469).  The Waiver has been introduced with the stated aim of putting EU generic and...more

Robinson+Cole Manufacturing Law Blog

Deadlines Approaching: Large Manufacturers Must Submit 2017 and 2018 Pay Data

You may have been following the complex twists and turns involving the collection of employee pay and demographic data by the EEOC. ...more

Troutman Pepper

PFAS to Drive Environmental Enforcement in 2019

Troutman Pepper on

Perfluoroalkyl and polyfluoroalkyl substances (PFAS), a group of manmade chemicals that have been used in various manufacturing processes throughout the past century, have made headlines around the country due to emerging...more

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

Hogan Lovells

The FDA now offers cGMP Declarations

Hogan Lovells on

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more

Robinson+Cole Manufacturing Law Blog

TRAINING DEADLINE EXTENDED: Time to Catch the “Train” – The New York Gender-Based Harassment Train

Last month, I posted about New York State’s recently enacted law mandating all New York State employers adopt Sexual Harassment Policies and train all employees annually. ...more

Troutman Pepper

California Becomes First State to Regulate IoT Devices

Troutman Pepper on

On September 28, Governor Jerry Brown approved California Senate Bill 327, making California the first state in the country to regulate the security of Internet of Things (IoT) devices. ...more

Hogan Lovells

What would a no-deal Brexit look like for the UK chemicals industry?

Hogan Lovells on

The UK government has recently published a technical notice to guide businesses that produce, register, import or export chemicals on what they will need to do if the UK leaves the EU in March 2019 in a 'no deal' scenario...more

Hogan Lovells

CDRH's Voluntary Malfunction Summary Reporting Program

Hogan Lovells on

On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part of the Medical Device User Fee...more

Hogan Lovells

Legislative and Regulatory Update on Federal Supply Chain Risk Management

Hogan Lovells on

The U.S. Government is renewing its focus on mitigating technological risks by regulating the supply chain for various goods and services. ...more

Farrell Fritz, P.C.

Legislation Affecting the Pharmaceutical Industry

Farrell Fritz, P.C. on

During a year in which legislative activity was restrained by a variety of factors, most notably the Senate’s inability to maintain a consistent majority, the New York State Legislature nonetheless still passed 641 bills,...more

Hogan Lovells

Implications of European Commission’s proposal for a Regulation to modify existing EU rules to allow manufacturers to apply for...

Hogan Lovells on

On 4 June 2018, the European Commission adopted a proposal for a Regulation to modify existing EU rules to allow manufacturers of vehicles to obtain new approvals from the 27 EU Member States who will remain post-Brexit to...more

Polsinelli

Is your Company in Compliance with the New Warning Regulations under California’s Proposition 65?

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All consumer products sold or distributed into the State of California may be subject to new chemical warning regulations that go into effect in three months....more

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