Regulatory NewsRegulatory News
House subcommittee moves FDA $3.6B budget forward
Posted 15 June 2022 By Ferdous Al-Faruque
Lawmakers in the House Appropriations agriculture subcommittee have sent their FY 2023 budget package that includes funding for the US Food and Drug Administration (FDA) to the full committee, proposing $3.6 billion in discretionary fund...
This Week at FDAThis Week at FDA
Regulatory NewsRegulatory News
This Week at FDA: House advances user fee bill, FDA’s enterprise modernization ambitions, and another 510(k) pilot
Posted 20 May 2022 By Michael Mezher
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. It was a busy week for FDA on the Hill again, wit...
Regulatory NewsRegulatory News
Califf uses budget hearing to advocate for resources, authority to monitor supply chains
Posted 19 May 2022 By Ferdous Al-Faruque
A House appropriations subcommittee hearing on the proposed budget for the US Food and Drug Administration placed the agency’s commissioner, Robert M. Califf, on the hot seat, taking criticism for failing to prevent an infant formula sho...
Feature ArticlesFeature Articles
October’s Regulatory Focus: Linguistic review, advanced therapies in Asia-Pacific, and more
Posted 04 November 2021 By Renee Matthews
Feature articles during October included an in-depth look at the linguistic review process in Europe and  reviews of the regulatory pathways for herbal medicinal products, medical devices, and supplements in the EU and for advanced thera...
Feature ArticlesFeature Articles
EU regulation of herbal products, Part 1: Definitions, regulations, and documentation
Posted 27 October 2021 By Andrada Armasu, MPharm, RAC
This article compares and contrasts the regulatory requirements for herbal medicinal products, herbal-based medical devices, and botanical food supplements in the EU. It provides an overview of the current framework, highlights areas of ...
Regulatory NewsRegulatory News
Consent decree shuts down Utah herbal firm
Posted 20 October 2021 By Kari Oakes
The filing came after FDA issued a 2017 warning letter to the supplement manufacturer, which then continued marketing and selling its products with claims that made them unapproved and misbranded drugs, rather than the dietary suppleme...
Regulatory NewsRegulatory News
FDA warns companies for GMP violations, conducting trial without IND
Posted 13 October 2021 By Jeff Craven
A contact testing laboratory found in violation of Current Good Manufacturing Practice (CGMP) regulations and a nutritional supplement company conducting a clinical investigation without an investigational new drug application (IND) have...
ReconRecon
Recon: FDA vax approval signals looming mandates; Pfizer's $2.3B Trillium takeover
Posted 23 August 2021 By Kari Oakes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
     
  •  
  • 1
  •  
  • 2
  •  
  •  
Chapter Events Chapter Events
San Francisco Chapter Webcast: Cannabis: Where Are We Now?
Tuesday, 04 October 2022 (10:00 - 11:30AM) 1.5 RAC Credits Member: $0 |Nonmember: $25
This webcast will describe the terminology, and differences between FDA-approved and non-FDA approved cannabis, as well as an overview of current regulations of cannabis based products
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Dietary Supplements and NHPs [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of the regulatory requirements for dietary supplements in the US and for NHPs in Canada.
On-demand On-demand
Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
Books Books
Eclectic Science and Regulatory Compliance: Stories for the Curious
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
Books Books
Communication and Negotiation
Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
Books Books
Choosing the Right Regulatory Career
Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.
Books Books
Key Regulatory Topics: eCTD
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
Books Books
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
Books Books
EU Regulatory Acronyms & Definitions, Sixth Edition
Member : $10.00 Nonmember: $15.00
An EU reference guide with entries in biologics, medicinal products, and medical devices.
     
  •  
  • 1
  •  
  • 2
  •  
  •  

All Results

Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Regulation of Dietary Supplements and NHPs [3.0 RAC]

3.0RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of the regulatory requirements for dietary supplements in the US and for NHPs in Canada.
On-demand On-demand

Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
Chapter Events Chapter Events

San Francisco Chapter Webcast: Cannabis: Where Are We Now?

Tuesday, 04 October 2022 (10:00 - 11:30AM)
1.5RAC Credits
Member: $0 |Nonmember: $25
This webcast will describe the terminology, and differences between FDA-approved and non-FDA approved cannabis, as well as an overview of current regulations of cannabis based products
Books Books

Eclectic Science and Regulatory Compliance: Stories for the Curious

Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
Books Books

Communication and Negotiation

Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
Books Books

Choosing the Right Regulatory Career

Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.