Tag Archives: manufacturers

Pharmaceutical Manufacturers Must Submit 340B Ceiling Prices Starting in the First Quarter of 2019

By David C. Gibbons & Alan M. Kirschenbaum — Beginning February 15, drug manufacturers will have a new price to report to the Federal government: 340B ceiling price.  Under Section 340B of the Public Health Service Act, a manufacturer of … Continue reading

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FDA is “Discouraged” by Dearth of HCT/P Manufacturers that have Reached Out to Agency During Enforcement Discretion Period

By Mark I. Schwartz — In November of 2017, FDA published its enforcement discretion policy regarding HCT/Ps that don’t meet all four criteria under 21 CFR 1271.10(a): To give manufacturers time to determine if they need to submit an IND … Continue reading

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FCA fines household appliance manufacturers €189 million for cartel activities

On December 5, 2018, the French Competition Authority (FCA) fined six large household appliance manufacturers a total of €189 million for agreeing on price increases charged to end-consumers and commercial terms applicable to their kitchen installers. This is the tenth … Continue reading

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Manufacturers Have Strict Liability with Product Defects

When a defective or unexpectedly dangerous product injures you, you can file a product liability lawsuit to collect personal injury compensation. Most product liability cases in Illinois fall under the theory of strict liability, which means that you do not have … Continue reading

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E-Smoke and Mirrors: Why Expecting E-Cigarette Manufacturers to Solve Teen Vaping is Futile

By: Jake Plovanic In September, the U.S. Food and Drug Administration (FDA) gave Juul Labs and four other manufacturers of e-cigarettes 60 days to provide a detailed plan for keeping their products out of the hands of the nation’s youth. … Continue reading

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