Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Les nouveaux avenants à l’accord cadre. La mise en pratique des préparations hospitalières spéciales et l'avenant à l'accord-cadre sur les hausses de prix à l'aune de la souveraineté sanitaire....more
Un nouveau dispositif, porté par le projet de loi de financement de la sécurité sociale pour 2024, pourrait aboutir à imposer aux entreprises exploitant un médicament mature d’intérêt thérapeutique majeur qui souhaiterait en...more
Le rapport Borne sur la régulation des produits de santé qui était très attendu est bien en deçà des attentes des acteurs du secteur. Très peu de propositions concrètes y figurent. La Première ministre Elisabeth Borne a lancé...more
L'arrêté ministériel fixant la Charte relative à la qualité des pratiques professionnelles de présentation, d'information ou de publicité des dispositifs médicaux à usage individuel, des autres produits de santé et de tout...more
The French ministerial order laying down the Charter on the quality of professional practices for the presentation, information or promotion of medical devices for individual use, other health products and any associated...more
France is generally known for its high quality and also highly regulated healthcare system. As an EU Member State, France has implemented the EU medicines and medical devices regimes. This chapter should therefore be read in...more
The Paris Court has ruled against Sanofi in the Depakine case on the class action initiated by an association. According to a parliamentary report dated 11 June 2020, only twenty-one class actions have been brought to court...more
Dans un rapport publié le 23 juin 2021, la mission d’information sur les médicaments de l’Assemblée préconise notamment la création d’un haut-commissaire aux produits de santé dont on peut légitimement se demander s’il sera...more
Les textes réglementaires d’application du nouveau dispositif d’accès précoce au 1er juillet ont été publiés. Les dispositions se veulent précises sur le cadre juridique d’instruction des demandes et la HAS et l’ANSM...more
Le Haut Conseil pour l’avenir de l’assurance maladie (HCAAM) a publié le 10 juin 2021 un rapport sur la régulation du système de santé. L’axe central de ce document repose sur la nécessité de définir une trajectoire de moyen...more
Retour sur la lettre de mission que les Ministres de tutelle du Comité économique des produits de santé viennent d’adresser à son Président alors que le nouvel accord-cadre « médicaments » est en passe d’être publié....more
Dans la continuité de son Plan d’action pour les médicaments innovants exposé début 2020, la Haute Autorité de santé a mis à jour sa doctrine d’évaluation des médicaments. ...more
Deadlines imposed by the public administration - All deadlines imposed by the public administration are suspended between March 12th and June 24th. The remaining deadline shall start to run again from the latter date...more
Amazon announced this week that it will spend $700 million to retrain a third of its US workforce to adapt to the increasing amount of robotic and automation technology in its warehouses. The 6-year effort will eventually...more
18 April 2019 Almost one and a half years after the launch of the sector inquiry, the French Competition Authority ("FCA") has released its conclusions on the functioning of competition in the pharmaceutical sector....more
On 22 February 2018, the French Health Authority (ANSM) published on its website its "Recommendations to applicants and holders of marketing and registration authorisations" on the names of medicines....more
In its 2018-2022 National Health Strategy, France aims for 80% biosimilar penetration by 2022, an increase from last year’s 70% target. France’s support for biosimilars is not new. ...more
On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more