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Risk Mitigation Risk Assessment Manufacturers

Kidon IP

Outsourced Manufacturing and Trade Secrets: Internal Controls (Part 4)

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When a company, for the soundest of business reasons, is exploring placing its crown jewels, its intellectual assets, in the hands of a third party, proper internal controls are vital. A company’s internal controls may...more

Alston & Bird

FDA Issues New Guidance on Nitrosamine Impurities in APIs and Drug Products

Alston & Bird on

Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and what manufacturers can do...more

Society of Corporate Compliance and Ethics...

The coronavirus provides an opportunity to hone crisis response plans for the next big challenge

Report on Supply Chain Compliance 3, no. 4 (February 20, 2020) - The coronavirus that has, at the time of writing, infected more than 40,000 people around the world and killed more than 1,000, is also ravaging...more

Seyfarth Shaw LLP

Auto Manufacturers: Don’t Forget the Amended Franchise Rule When Considering New Business Opportunities

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As competition intensifies and auto manufacturers and distributors look for new ways to realize value from their brands, they and their counsel would do well to familiarize themselves with the Federal Trade Commission’s (FTC)...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

Holland & Knight LLP

Congress Continues Push on Medical Device Cybersecurity Mandates - FDA Issues Medical Device Safety Action Plan; DHS Continues to...

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Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing risks coming from nation states, nonstate actors and other attackers. The...more

Dorsey & Whitney LLP

Risk Mitigation Strategies for Food and Beverage Companies: Five Prophylactic Measures

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Each year, food, beverage and agribusiness companies pay millions of dollars in settlements, penalties and judgments to consumers allegedly harmed through the sale, advertisement and manufacture of their products. The legal...more

King & Spalding

King & Spalding Lawyers Discuss The Regulatory Landscape At Medical Device Cybersecurity Risk Mitigation Conference

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On July 25 and 26, 2016, industry stakeholders assembled in Arlington, Virginia, to participate in the Medical Device Cybersecurity Risk Mitigation Conference sponsored by Q1 Productions. The conference focused on the...more

Foley & Lardner LLP

Class Action Lawsuits – Risks and Mitigation Strategies for Component Manufacturers

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Manufacturers of components incorporated into consumer products increasingly find themselves involved in product liability class action lawsuits. Manufacturers can be drawn into these types of lawsuits when their own customer...more

Foley & Lardner LLP

Protect Your Safety Investigations and Deliberations From Prying Eyes

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Every day companies deal with an ongoing safety analysis of their own products. These Safety Teams are routinely interdepartmental. The Safety Teams must consider design changes, manufacturing issues, potential recalls,...more

Searcy Denney Scarola Barnhart & Shipley

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

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