Regulatory NewsRegulatory News
Chinese firm warned for making OTC eye drops without microbiological safeguards
Posted 12 January 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) warned Chinese drugmaker Hubei Kangzheng for having inadequate microbiological controls to prevent contamination of its over-the-counter (OTC) eye drops. These violations partly stem from the fir...
Regulatory NewsRegulatory News
Recon: Califf's Senate hearing; Moderna, Amgen pull out of JPM
Posted 14 December 2021 By Kari Oakes
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.  
ReconRecon
Recon: Califf nomination timeline slips after Biden admin misses paperwork deadline; Canada fully approves J&J COVID vaccine
Posted 24 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA suggests alternative approaches for nitrosamine risk assessments
Posted 23 November 2021 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) has suggested that manufacturers consider using certain antioxidants or excipients, such as sodium carbonate, to their drug products to inhibit the formation of nitrosamine impurities.  
Regulatory NewsRegulatory News
This Week at FDA: mRNA boosters for most; Blood lancets reclassified
Posted 19 November 2021 By Kari Oakes, Michael Mezher
Welcome to our weekly digest of regulatory news from the US Food and Drug Administration (FDA), legislative updates, and other news updates we think you’ll find useful — and interesting. This week saw COVID-19 vaccine and therapy updates...
Regulatory NewsRegulatory News
This Week at FDA: CDRH and Endologix leaks, OTC monograph reform, and more
Posted 12 November 2021 By Kari Oakes
Welcome to week 2 of This Week at FDA . We've again gathered the week’s news from (and about) FDA. Each Friday, we'll be covering agency activities and enforcement actions, filings in the  Federal Register , new guidances, legislative u...
ReconRecon
Recon: WHO review of India's Covaxin underway; Novartis mulls spinoff of generic unit Sandoz
Posted 26 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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...
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Lifecycle Management Through the Rx-to-OTC Switch
Member: $145.00 Nonmember: $200.00
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.
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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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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.
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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.
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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.
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Key Regulatory Topics: eCTD
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
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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.
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From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories
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.
     
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Books Books

Lifecycle Management Through the Rx-to-OTC Switch

Member: $145.00 Nonmember: $200.00
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.