Regulatory NewsRegulatory News
FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires
Posted 21 October 2021 By Joanne S. Eglovitch
Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administratio...
Regulatory NewsRegulatory News
FDA issues proposed OTC hearing aid rule
Posted 19 October 2021 By Jeff Craven
The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale of over-the-counter (OTC) hearing aids for adults with mild and moderate hearing loss.
Regulatory NewsRegulatory News
FDA official breaks down novel excipient pilot program
Posted 11 October 2021 By Kari Oakes
Although a new excipient might offer advantages such as better drug bioavailability, enhanced absorption, or the potential for a more abuse-deterrent formulation for opioids, for example, the development process can be slowed when FDA do...
Current good manufacturing practices and quality system design
Posted 04 October 2021 By Joscelyn Bowersock, MS, Richard Vincins, RAC
Quality by design, or the principle of building quality into a product and testing, was introduced in 2011 as process validation guidance. Today it is codified within the Title 21 section 820. The quality management system (QMS) encompas...
RAPS' LatestRAPS' Latest
New book covers essential lessons of Rx-to-OTC switch
Posted 30 September 2021 By Zachary Brousseau
When a prescription medicine is reclassified to be made available without a prescription, it is known as an Rx-to-OTC switch. RAPS’ new book, Lifecycle Management Through the Rx-to-OTC Switch , was developed to help regulatory professio...
Regulatory NewsRegulatory News
FDA unveils proposed changes to OTC sunscreen labeling, active ingredients
Posted 24 September 2021 By Mary Ellen Schneider
The US Food and Drug Administration is proposing several changes for over-the-counter (OTC) sunscreen products, from new labeling requirements to substantially reducing the number of active ingredients to be generally recognized as safe ...
Regulatory NewsRegulatory News
Three foreign OTC firms slapped with warning letters for GMP testing violations
Posted 23 September 2021 By Joanne S. Eglovitch
Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one of the led the US Food and Drug Administration (FDA) to issue two warning letters to manufacturers located outside the US. Additionally, the a...
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Books Books
Lifecycle Management Through the Rx-to-OTC Switch (Paperback)
Member: $125.00 Nonmember: $175.00
Lifecycle Management Through the Rx-to-OTC Switch is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
Books Books
Key Regulatory Topics: eCTD (Paperback)
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
Books Books
Promotion of FDA-Regulated Medical Products (Paperback)
Member: $125.00 Nonmember: $175.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
Books Books
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD (Paperback)
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
Eclectic Science and Regulatory Compliance: Stories for the Curious (Paperback)
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
From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories (Paperback)
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 (Paperback)
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 (Paperback)
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.
     
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Europe Europe
Books Books

Lifecycle Management Through the Rx-to-OTC Switch (Paperback)

Member: $125.00 Nonmember: $175.00
Lifecycle Management Through the Rx-to-OTC Switch is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
Regulatory NewsRegulatory News

FDA FY2022 user fee table

Books Books

Key Regulatory Topics: eCTD (Paperback)

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

Promotion of FDA-Regulated Medical Products (Paperback)

Member: $125.00 Nonmember: $175.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.