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Online Course

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

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

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

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.

On-demand

FDA Forecast: What's Next for the FDA in 2023? (On-Demand)

1.5RAC Credits

Member: $0 | NonMember: $25
What will the FDA do in 2023? In this timely, lively and informative event, regulatory analysts from POLITICO's AgencyIQ will explain what regulatory professionals should anticipate in the year ahead.

Virtual Programs

Nutrition, Health, and Disease: Regulatory Policy Matters

Member: $145.00 Nonmember: $200.00
This book depicts the importance of nutrition and the gut microbiome in noncommunicable chronic diseases (NCD) prevention and management.

Books

Key Regulatory Topics: eCTD

Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.

Books

Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition

Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.

Virtual Programs

Preparing for an FDA PAI or BIMO Inspection

Wednesday, 29 March 2023 (12:00 - 1:30PM)

1.5RAC Credits

Member: $175 | NonMember: $200
This workshop will provide a thorough understanding of how to prepare for an FDA PAI or BIMO inspection, including Inspection Readiness plans, Gap Analysis and Remediation, and Inspection Logistics.

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.

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News Search

Regulatory News

This Week at FDA: Becerra asks for new authorities; FDA issues guidances, reports

Posted 24 March 2023 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. It’s been a busy week for the agency as Xavier B...

Regulatory News

Becerra asks for supply chain monitoring authorities, incentives for antimicrobial drugs

Posted 23 March 2023 By Ferdous Al-Faruque

The head of the US Department of Health and Human Services (HHS) is asking lawmakers for additional authorities to track product supply chains to avoid shortages and the need to give incentives to antimicrobial drug manufacturers to deve...

Regulatory News

FDA’s top cybersecurity officials discuss heightened threats, technology modernization

Posted 20 March 2023 By Ferdous Al-Faruque

In a nondescript building in North Bethesda, Maryland, the US Food and Drug Administration (FDA) houses a cybersecurity control center responsible for protecting its digital assets. Since the beginning of the COVID-19 pandemic, the agenc...

Regulatory News

This Week at FDA

This Week at FDA: FDA’s budget justification, Nurtec ODT recall, and more

Posted 17 March 2023 By Michael Mezher • 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, FDA released more details on its FY20...

Regulatory News

FDA seeks 10% boost in Biden’s FY 2024 budget

Posted 09 March 2023 By Ferdous Al-Faruque

The US Food and Drug Administration’s (FDA) is seeking to increase its budget authority by 10% in fiscal year 2024 as part of the Biden administration’s $6.9 trillion budget request. While the budget request also includes multiple legisl...

Regulatory News

HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules

Posted 21 February 2023 By Ferdous Al-Faruque

The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year. It includes several rules that the Food and Drug Administration (FDA) will work on to addr...

Regulatory News

This Week at FDA

This Week at FDA: Califf calls for adcomm reform, first OTC naloxone may be on horizon

Posted 17 February 2023 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, FDA Commissioner Robert Califf called...

Regulatory News

This Week at FDA: Restructuring at inspections office, new guidances and staff, and more

Posted 03 February 2023 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 agency announced the launch of a ...

Regulatory News

FDA proposes streamlining inspections office along with new human foods center

Posted 31 January 2023 By Ferdous Al-Faruque

The US Food and Drug Administration has proposed restructuring the Office of Regulatory Affairs (ORA) as part of its efforts to reform its food safety oversight program. Agency heads say the changes will eventually mean more efficiencies...

Regulatory News

OIG report highlights shortcomings in FDA’s IT acquisition procedures

Posted 18 January 2023 By Ferdous Al-Faruque

The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) is calling on the Food and Drug Administration (FDA) to improve its processes for buying information technology (IT). Overall, the oversight agency de...

Regulatory News

FDA looking externally and internally to develop future IT leaders

Posted 16 January 2023 By Ferdous Al-Faruque

The US Food and Drug Administration (FDA) recently published a report on its plans to prioritize developing a cadre of leaders who can streamline its information technology infrastructure and develop plans to make their systems more effi...

Regulatory News

FDA official says pandemic reauthorization bill could drive VALID across finish line

Posted 13 January 2023 By Ferdous Al-Faruque

A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro diagnostics reform and discussed other legislative priorities for the agency, such as getting more...

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Event Calendar

Virtual Programs

Preparing for an FDA PAI or BIMO Inspection

Wednesday, 29 March 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $175 | NonMember: $200
This workshop will provide a thorough understanding of how to prepare for an FDA PAI or BIMO inspection, including Inspection Readiness plans, Gap Analysis and Remediation, and Inspection Logistics.

Books | Learning

Books

Terms & Definitions of Japanese Regulatory Affairs

Member: $32.50 Nonmember: $42.50
English translations of the most important Japanese regulatory terms and acronyms.

Books

Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations

Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.

Books