Regulatory NewsRegulatory News
FDA announces website for complex generics
Posted 05 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development.  
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This Week at FDA: New guidance on disposable manufacturing materials, Generic Drug Cluster report
Posted 29 July 2022 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 US Food and Drug Administration (F...
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Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition
Posted 01 July 2022 By Ryan Connors
Regulatory professionals need a new guide to medical device regulations. We just wrote one.
Regulatory NewsRegulatory News
FDA explains plans to bolster cell and gene therapy approvals through wider messaging
Posted 19 May 2022 By Joanne S. Eglovitch
Wilson Bryan director of the US Food and Drug Administration’s Office of Tissues and Advanced Therapies (OTA) in the agency’s Center for Biologics Evaluation and Research, told a 19 May meeting of the Association for Cell and Gene Therap...
Regulatory NewsRegulatory News
FDA official discusses common deficiencies derailing ANDAs
Posted 27 April 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) rejected a fewer number of abbreviated new drug applications (ANDAs) in FY 2021 through its refuse-to-receive (RTR) mechanism compared to previous years, said Peter Enos, a reviewer with the agen...
Regulatory NewsRegulatory News
FDA proposes framework for updated COVID vaccines to spur discussion
Posted 06 April 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has presented a framework to update the composition of COVID-19 vaccines based on new strains. During a meeting with its Vaccines and Related Biological Products Advisory Committee (VRBPAC), the ...
Regulatory NewsRegulatory News
Inspections emerge as flashpoint in BsUFA II assessment meeting
Posted 23 March 2022 By Michael Mezher
Biosimilar industry groups expressed frustration at the lack of transparency and communication from the US Food and Drug Administration (FDA) on inspections during the COVID-19 pandemic during a meeting to review the final assessment rep...
Regulatory NewsRegulatory News
FDA, EMA tout benefits of parallel scientific advice program
Posted 17 March 2022 By Joanne S. Eglovitch
Regulators described how the parallel scientific advice (PSA) program offered by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) saves sponsors time and resources by bringing both health authorities to t...
     
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How to Effectively Talk to Regulators
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How Huvepharma Maintains Quality and Innovation in a High Growth Environment
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Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
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Speakers will review the history of quality systems, look at the changes to quality regulations and discuss the FDA’s intent to adopt the ISO 13485 standard.
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The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment
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This webcast will not try to predict how the geopolitical world will change as a consequence of COVID-19, but will cover current hot topics and emerging challenges affecting regulatory affairs professionals globally.
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Stay on Track and Get Some Sleep: Marketing Application Best Practices
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Regulatory experts will offer tips and guidance for acceleration, submission leadership, and regulatory strategy from that you can apply to your marketing application to help ensure a successful submission.
     
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