Regulatory NewsRegulatory News
FDA warning letter tells Spanish API firm to up its validation game
Posted 22 July 2022 By Joanne S. Eglovitch
A Spanish producer of active pharmaceutical ingredients (API) was chastised by the US Food and Drug Administration (FDA) in a June 30 warning letter for its spotty approach to validation and ensuring that manufacturing processes remain...
Regulatory NewsRegulatory News
Stakeholders seek tweaks to FDA’s voluntary improvement program guidance
Posted 08 July 2022 By Jeff Craven
The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to know mor...
Regulatory NewsRegulatory News
FDA tells Dutch API producer to clean up its equipment act
Posted 01 July 2022 By Joanne S. Eglovitch
A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Admin...
Regulatory NewsRegulatory News
ICMRA explores hybrid inspections, postapproval changes with new pilots
Posted 29 June 2022 By Joanne S. Eglovitch
A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.  
Regulatory NewsRegulatory News
FDA caught up on domestic preapproval inspections, foreign inspections still a challenge
Posted 20 June 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) eliminated its backlog of overdue domestic preapproval inspections, yet such progress has been stunted at the international level as getting to sites in China has remained a challenge amid the co...
Regulatory NewsRegulatory News
House GOP reps question FDA commissioner on drugs with China-only data, trial site inspections
Posted 25 May 2022 By Jeff Craven
Republicans in the House Committee on Energy and Commerce have sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf asking him to provide information about drugs approved solely based on data from clinical tr...
Regulatory NewsRegulatory News
User fee reauthorization bill advances in the House, Senate eyes different riders
Posted 18 May 2022 By Ferdous Al-Faruque
The House Energy and Commerce committee voted unanimously to send legislation to reauthorize the US Food and Drug Administration’s (FDA) user fee programs to the floor in a 55-0 vote. The bill has significantly different riders from one ...
Regulatory NewsRegulatory News
FDA updates guidance on evaluating out-of-specification results for drugs
Posted 18 May 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) has revised its 16-year-old final guidance on procedures for reviewing out-of-specification (OOS) results in the laboratory, including the responsibilities of the analyst and supervisor in report...
     
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