Health news and commentary from around the Web gathered by the ALLMedPage Today staff
Experts react to role of distributors, legislation in opioid crisis
FDA working with manufacturers to prevent shortages
New era for lymphoma, leukemia, possibly other cancers
We are pleased to announce that KKB partners Dan Dwyer, Stacy Ehrlich, Peter Mathers, and Suzan Onel were selected for the annual Super Lawyers list for Washington, DC. They make up more than 20% of the 18 DC attorneys listed in the “Food and Drugs” category. In addition, for the sixth year in a row, KKB
The post KLEINFELD, KAPLAN & BECKER WELL REPRESENTED ON THE WASHINGTON, DC, 2020 SUPER LAWYERS LIST FOR “FOOD AND DRUGS” appeared first on Kleinfeld Kaplan & Becker LLP.
#TTB just made changes to modernize the way that #wine, #distilledspirits, and #maltbeverages are labeled and advertised. KKB associate Dan Logan and partner Dan Dwyer highlight some of the key changes (and proposals that were rejected).
The post TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule appeared first on Kleinfeld Kaplan & Becker LLP.
Join Kleinfeld, Kaplan & Becker, LLP and Vicente Sederberg on Tuesday, April 7 at 2:15 p.m. ET for a live webinar on Hemp and CBD – FDA Update and the Impact of COVID-19. Since 2015, KKB and VS have worked closely together in advising clients on the ever-evolving legal landscape for hemp-derived products. During this
The post LIVE WEBINAR: Hemp & CBD: FDA Update and the Impact of COVID-19 appeared first on Kleinfeld Kaplan & Becker LLP.
By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA). The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these
The post Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.
By: Daniel Dwyer and Daniel Logan On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. Law 116-136), which includes a comprehensive revision of the rules governing over-the-counter (OTC) drugs currently marketed under monographs published by the Food and Drug Administration (FDA). This law
The post New Opportunities for OTC Monograph Drugs under the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.
By: Suzan Onel FDA issued a Press Release on March 28, 2020, reiterating what we all have seen in the news, there is a severe shortage of personal protective equipment (PPE) in health care facilities across the country. In response to the shortages, FDA has issued Emergency Use Authorizations (EUAs) for respirators, ventilators, ventilator tubing
The post Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer? appeared first on Kleinfeld Kaplan & Becker LLP.
By: Stacy Ehrlich and Justine E. Johnson On March 18, 2020, the Food and Drug Administration (FDA) published a final rule (21 C.F.R. Part 1141) requiring textual and graphic health warnings to be included on all cigarette packages and advertisements.[1] FDA simultaneously published two related guidance documents: (1) Required Warnings for Cigarette Packages and Advertisements,
The post FDA ISSUES FINAL RULE ON GRAPHIC WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS appeared first on Kleinfeld Kaplan & Becker LLP.
By: Jacqueline Chan and Vanessa Fulton Consumers are increasingly demanding environmentally-friendly products and packaging. Driven by this increased demand and desire to create positive environmental change, companies are working hard to shift to more sustainable materials and packaging and seeking to communicate such efforts to consumers through product labels and advertising. “Recyclable.” “Biodegradable.” “Made of
The post It’s Not Always Easy Being Green – Lawsuit Related to “Recyclable” Claims Highlights Risks Related to Environmental Benefit Claims appeared first on Kleinfeld Kaplan & Becker LLP.
By Suzan Onel and Vanessa Fulton On March 19, 2020, FDA issued a guidance document communicating its policy regarding postmarket adverse event reporting during a pandemic (“Guidance”). The Guidance provides recommendations that affect adverse event reporting obligations for drugs, biologics, medical devices, combination products, and dietary supplements. To summarize, FDA states in the Guidance that
The post FDA Waives Certain Adverse Event Reporting Deadlines Across Product Industries During Pandemics appeared first on Kleinfeld Kaplan & Becker LLP.
By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consistent with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA),
The post FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD appeared first on Kleinfeld Kaplan & Becker LLP.
Une étude rapporte que les patients cancéreux sont jusqu’à 6 fois plus à risque de développer des complications sévères et de décéder de la Covid-19.
Cette semaine, je propose à nouveau des idées de desserts et collations nutritives qui sauront plaire à toute la famille.
Des observations indiquent qu’une forte proportion des patients touchés par la COVID-19 présentent des atteintes au cœur et aux vaisseaux sanguins.
La moitié des jeunes adultes vivent une anxiété profonde et présentent des symptômes de dépression depuis le début de la crise sanitaire.
L’obésité représente un important facteur de risque d’entraîner les plus graves complications cliniques associées aux formes sévères de COVID-19.
Voici des inspirations de desserts et collations qui allient plaisir et santé!
Jean-Yves Dionne explique ce qu’est le stress – le bon comme le moins bon – et propose des façons de mieux le gérer.
Cette semaine, on découvre les produits du Québec qui s’inscrivent dans les tendances alimentaires de l’année.
Comment réagir devant quelqu’un qui se braque ou minimise, parfois jusqu’à l’excès, le danger de la COVID-19 ?
Les données recueillies jusqu’à maintenant révèlent qu’environ 2 fois plus d’hommes que de femmes décèdent de la maladie à coronavirus.
Des restaurateurs ont fait preuve de créativité et d’efficacité en élaborant un menu pour emporter.
Les études réalisées jusqu’à maintenant montrent qu’une proportion des patients sont affectés par une condition de santé précaire.
Conseils de pro pour continuer à bien manger en temps de confinement.
«Bikini body» versus silhouette bedonnante... Sur les réseaux sociaux, l’affaire est entendue: le confinement se traduira par des kilos en plus.
Entre l’éprouvette et la pharmacie, près de 15 ans peuvent s’écouler pour qu’une molécule d’intérêt thérapeutique devienne un médicament.
Ryan Maguire is CTO & VP of emerging capabilities and partnerships at Kin + Carta. Prior to navigating our way through social distancing, Ryan and I connected about his work at Kin + Carta, a business "built for the 2020's" - with a collaborative ecosystem of 1,600 strategists, engineers, and creatives across four continents.
When we last checked in, like so many of us, Ryan and his teams are spending their time closely monitoring and manoeuvring the impacts COVID-19 on their business, clients and investors. However, here is the conversation we had in early March.
Keep on reading: Quick Answers to Quick Questions: Ryan Maguire, CTO & VP, KIN + Carta
The National Venture Capital Association (NVCA) is closely monitoring the outbreak of the coronavirus (COVID-19) and is working diligently to address the VC industry’s needs and provide resources that aim to help firms and portfolio companies during this challenging time. This webpage provides important information and resources to venture-backed companies about the federal response to COVID-19, including tax credits, loan opportunities, and sick leave. NVCA will update this information as it becomes available.
Keep on reading: Coronavirus Information and Resources for VCs and Startups
This year will likely bring far less unicorn hype, but tech firms with promising business models and profit outlooks could be poised for healthy IPOs in 2020.
Keep on reading: 5 Tech IPOs to Watch for in 2020
Subscription focused, The Athletic has grown rapidly since its start in 2016. Founded by Adam Hansmann and Alex Mather, the VC-backed sports website, has bucked the trend by focusing on annual subscriptions. And with its latest funding of $50 million, the company is now worth $500 million.
Keep on reading: Sports writing startup hits $500M valuation
In 2018 there were 15 unicorns born with at least one female founder. This year, there were 21 startups founded or co-founded by a female that became unicorns.
Keep on reading: Female-founded Unicorns Were Born at an Unprecedented Pace in 2019
In February 2019, CB Insights announced their third annual AI 100 - a list of the 100 most promising AI startups across the globe. And today, they're recapping where those companies made it in the past 12 months.
Keep on reading: AI Startups of 2019: Where Are They Now?
Le pionnier américain du rock and roll, Little Richard, meurt à l’âge de 87 ans, rapporte le magazine Rolling Stone.
En ce week-end de la fête des Mères, pleins feux sur quelques mamans fictives qui veillent sur leur progéniture.
Tourner une émission de variétés réunissant 80 artistes en pleine pandémie, c’est tout un casse-tête.
Pour lui rendre un hommage hautement mérité, les membres de l’équipe des Arts et spectacles du Journal a choisi une chanson coup de cœur des Colocs.
Plus de 500 employés de Vidéotron vont prendre les appels des Québécois, dimanche, pendant l'émission spéciale «Une chance qu’on s’a».
Sorti le 5 mai 2000 sur les écrans nord-américains, le «Gladiateur» de Ridley Scott a permis à Russell Crowe de mettre la main sur son unique Oscar.
Notre sélection des sorties du mois sur Club illico
France Beaudoin animera une émission spéciale fête des Mères d’En direct de l’univers samedi soir.
Il fallait du cran pour s’attaquer au cultissime Rabid de David Cronenberg. Ça tombe bien, car les sœurs Soska n’en manquent pas. Loin de là.
En quoi ce nouveau service d’écoute musicale en continu va se démarquer de ses gigantesques rivaux sur le marché. Explications en cinq points.
Au cours des trois dernières décennies, les artistes québécois se sont souvent ralliés, le temps d’une soirée, derrière une même cause.
Le cinéaste Ken Scott a obtenu vendredi le feu vert de la SODEC pour le tournage de son prochain film, «Au revoir le bonheur».
Porte-parole de QUB Musique avec Alex Nevsky et Guylaine Tanguay, Yann Perreau passe son confinement en famille à son chalet de Lanaudière.
Guillaume Lemay-Thivierge n’allait pas être complètement stoppé dans son élan par le confinement. C’était une question d’équilibre mental.
L’entreprise Vignoble et Cidrerie Coteau Rougemont a implanté un système de livraison dès la deuxième semaine du confinement.