On July 3, 2023, the European Medicines Agency (“EMA”) and the European Commission published a Guidance on Parallel EMA/HTA body Scientific Advice for the Interim Period (“Guideline”).
The Guideline organizes parallel...more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more
1/10/2023
/ Animal Testing ,
Asbestos ,
Cosmetics ,
Distributors ,
Draft Guidance ,
EU ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Labeling ,
Manufacturers ,
New Regulations ,
PFAS ,
Product Recalls ,
Product Safety Labels ,
Suspensions
On July 14, 2022, the European Commission (“EU Commission”) published a proposal to adopt an EU-wide Regulation on standards of quality and safety for substances of human origin intended for human application...more
An ordinance (« arrêté ») was published in the French Official Gazette of 8 March 2022 that sets out a quality charter overseeing the professional practices of individuals responsible for the presentation of educational...more
Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more
2/9/2022
/ Clinical Trials ,
Data Privacy ,
Deadlines ,
Disclosure Requirements ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Life Sciences ,
Member State ,
New Regulations ,
Proposed Regulation ,
Reporting Requirements ,
UK
This year – 2022 – may finally be the year that the effort to modernize safety standards in the U.S. for cosmetics and other personal care products, which has been ongoing since 2013, comes to fruition. If so, the new...more
1/27/2022
/ Best Practices ,
Cosmetics ,
EU ,
European Commission ,
Food and Drug Administration (FDA) ,
Hazardous Substances ,
Personal Care Products ,
PFAS ,
Preemption ,
Product Labels ,
Product Recalls ,
Proposition 65 ,
REACH ,
State Bans ,
Toxic Chemicals
On 19 November 2020, the European Court of Justice (“ECJ”) ruled on the French ban of cannabidiol (“CBD”) extracted from whole hemp plants in a case relating to the marketing and distribution of hemp oil containing CBD (case...more
12/1/2020
/ Bulgaria ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Czech Republic ,
EU ,
European Court of Justice (ECJ) ,
France ,
Hemp ,
Narcotics ,
Slovakia ,
Sweden ,
Treaty on the Functioning of the European Union (TFEU) ,
Vaping
France is finally moving forward on the medical use of cannabis. At the end of 2019, Law No. 2019-1446 indicated that French law would allow for a trial for medical use of cannabis-based products. The decree and implementing...more
On 23 September 2020, in a landmark case, Medac v Commission, the trial-level General Court (“GC”) of the European Union (“EU”) annulled the decision of the European Commission (“EU Commission”) that had withdrawn the orphan...more
Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.” If finalized, the rule would amend...more
The European Commission (Commission) has released a Staff Working Document concerning its joint evaluation of the Orphan Regulation and the Paediatric Regulation (collectively, the Regulations) (Joint Evaluation) and an...more
The two arrêtés [orders] setting thresholds for transfers of value from pharmaceutical and medical devices companies to healthcare professionals, institutions, and other actors of the healthcare sectors (Healthcare...more
In France, Ordinance No 2017-49 of 19 January 2017 significantly modified the rules governing payments from life sciences companies to the healthcare sector. After more than three years, on June 15, 2020, Decree No 2020-730...more
In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their...more
The Food and Drug Administration (“FDA”) as well as the European Medicines Agency (“EMA”) and the national Heads of Medicines Agencies (“HMA”) issued new guidance for industry sponsors, investigators, and Institutional Review...more
The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more