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Elmiron

Elmiron

Janssen Pharmaceuticals is facing lawsuits over the link between Elmiron (pentosan polysulfate sodium), a drug used to treat Interstitial Cystitis (also known as Painful Bladder Syndrome) and a dangerous eye condition known as Retinal Maculopathy.

3M Combat Earplugs

3M Combat Earplugs

Due to an alleged design defect, the earplugs do not maintain a tight seal and may have caused hearing problems for some soldiers. More than 140,000 veterans and active duty personnel are now suing 3M, claiming that the manufacturer knowingly sold defective earplugs to the military.

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Juul Vaporizers (E-Cigarettes)

Health

Juul Vaporizers (E-Cigarettes)

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Juul's vape oil contains nicotine, a highly addictive substance. Many of these oils also contain otherwise innocuous substances that may become harmful when vaporized and inhaled.

Dicamba

Dicamba

Dicamba is an herbicide that allegedly can move offsite, reducing crop yield. Many farmers have filed lawsuits against manufacturers seeking compensation for crop losses.

Docket Number:
FDA-2020-D-1138
Issued by:
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FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for healthcare personnel (HCP)1 for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled 'Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,' available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

Submit Comments

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Vermicompostingteach to be happy. You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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If unable to submit comments online, please mail written comments to: Film scenesmac drama korea.

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1138.

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