Regulatory NewsRegulatory News
FDA-led study highlights tradeoffs in drug promotion on social media
Posted 11 August 2022 By Mary Ellen Schneider
Providing both benefit and risk information within character-space-limited (CSL) drug promotions on social media platforms like Twitter improved recognition of risks but made it less likely that consumers would click links for additional...
Regulatory NewsRegulatory News
This Week at FDA: New guidance on disposable manufacturing materials, Generic Drug Cluster report
Posted 29 July 2022 By Ferdous Al-Faruque
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, the US Food and Drug Administration (F...
Regulatory NewsRegulatory News
FDA offers new guidance on therapeutic equivalence evaluations
Posted 20 July 2022 By Michael Mezher
In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment of therapeutic equivalence codes, which are listed in the agency’s Ora...
RoundupsRoundups
Euro Roundup: COVID vaccines drive 93% jump in EudraVigilance reports
Posted 21 April 2022 By Nick Paul Taylor
The number of authorized product suspected adverse reactions sent to EudraVigilance jumped 93% last year because of a surge in reports related to COVID-19 vaccines. Almost half of the record 3.5 million individual case safety reports (IC...
Regulatory NewsRegulatory News
Stakeholders ask for more time to transition EUA devices, diagnostics
Posted 25 March 2022 By Ferdous Al-Faruque
Responding to two US Food and Drug Administration (FDA) draft guidances on transitioning products granted emergency use authorization (EUA) during the pandemic to regular marketing authorizations, key stakeholders raised concerns the age...
Regulatory NewsRegulatory News
EMA releases draft guidelines on GVP for pregnancy prevention programs
Posted 15 March 2022 By Jeff Craven
The European Medicines Agency (EMA) has released a guideline on good pharmacovigilance practices (GVP) for pregnancy prevention programs in the European Union for public consultation.
Regulatory NewsRegulatory News
OPDP’s first warning letter of 2022 targets CytoDyn for COVID claims
Posted 22 February 2022 By Michael Mezher
The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent a rare warning letter – its first for 2022 – to CytoDyn after the company posted a video interview last September of its then-CEO Nader Pourhas...
RoundupsRoundups
Asia-Pacific Roundup: New Zealand seeks feedback on harm warning on opioid labels
Posted 22 February 2022 By Nick Paul Taylor
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on its plans to add a warning about risks of overdose and dependence to the labels of opioid medicines -- and more, in our Roundup. 
     
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Virtual Programs Virtual Programs
US Regulation of Advertising and Promotion for Drugs and Biologics (2022)
Thursday, 11 August 2022 (12:00 - 4:00PM) 6.0 RAC Credits Members: $580 | Nonmembers: $680
Examine requirements, guidelines, and expectations for advertising and promotion of pharmaceuticals in the US.
Virtual Programs Virtual Programs
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development
Thursday, 22 September 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $0
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
On-demand On-demand
Meet the Author, International Combination Products, First Edition
Member: $0.00 Nonmember: $20.00
Hear from the expert who wrote the book!
Online Course Online Course
Pharmaceutical Labeling: Introduction to an Essential Function
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course is designed to expand the understanding of regulatory professionals about the activities, documents, and responsibilities involved in labeling healthcare products.
On-demand On-demand
How Huvepharma Maintains Quality and Innovation in a High Growth Environment
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand
Sponsored Webcast: Why UDI is a Regulatory Issue and Not Just an Operational Process (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Simplify UDI complexity by exploring requirements across several major markets, including the types of devices that are covered and the expected implementation timelines.
On-demand On-demand
Effective Labeling Management Requires a New Mindset : A Strategic Guide to Labeling Process Optimization
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review the best methods to evaluate factors that could affect product labeling management.
On-demand On-demand
Update Your Medical Device UDI Data and Labels: This Year FDA Class I / Next Year EU MDR
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Join speakers from Reed Tech Life Sciences and NiceLabel for an interactive webcast focused on two compliance areas they are monitoring closely.
Books Books
Promotion of FDA-Regulated Medical Products
Member: $130.00 Nonmember: $180.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
     
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