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Manufacturers object to provisions in FDA’s microbiological quality guidance
Posted 10 January 2022 By Joanne S. Eglovitch
An industry trade group and pharmaceutical manufacturers are calling for revisions to the US Food and Drug Administration’s (FDA) draft guidance on microbiological quality considerations for non-sterile drugs (NSDs), which they say propo...
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New reports address generics pricing, innovation in the EU
Posted 01 December 2021 By Kari Oakes
A European generics trade association is calling for relaxation of “extreme cost containment policies” against generic medicines, asserting that such measures are counterproductive and may endanger the supply chain through consolidation ...
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Recon: Blueprint's $250M preclinical buy; WHO, CDC, Biden react to Omicron variant
Posted 29 November 2021 By Kari Oakes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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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.  
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Nitrosamine detection tests should be 'fit for purpose,' says FDA
Posted 01 November 2021 By Joanne S. Eglovitch
Pharmaceutical manufacturers should ensure that the analytical tests they are using are “fit for purpose” to ensure that the right test is measuring the right impurity in testing their drugs for nitrosamines, says Jason Rodriguez, direct...
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Recon: FDA staff say Pfizer vaccine's benefits outweigh risks in kids ahead of adcomm; Biden meet with Califf as commissioner search narrows
Posted 25 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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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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WHO seeks input on medicines to prioritize for BCS-based biowaivers
Posted 27 September 2021 By Michael Mezher
The World Health Organization (WHO) is seeking input on the fourth set of medicines to prioritize for biopharmaceutics classification system (BCS)-based biowaivers to ease in vivo study requirements for generic drugs.
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Preparing to Take the RAC Drugs Exam
Tuesday, 08 February 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 |Non-members: $1,150
Designed specifically for those preparing to take the RAC Drugs exam, workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
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RAC Drugs Examination Autumn 2022
Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
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RAC Drugs Examination Spring 2022
Member: $490.00 Nonmember: $615.00
Testing Window : 21 March 2022 To 29 April 2022
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RAC Drugs Examination Summer 2022
Member: $490.00 Nonmember: $615.00
Testing Window : 11 July 2022 To 19 August 2022