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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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The US Food and Drug Administration (FDA) recently sent an untitled letter to Connecticut-based contract testing lab Valisure for failing to comply with the Drug Supply Chain Security Act (DSCSA) and for findings of “methodological deficiencies” in the company’s analytical testing laboratory.
The European Commission’s Medical Device Coordination Group (MDCG) has adopted a definition for “hybrid audits” that offers notified bodies flexibility in terms of how long an auditor is physically present on the auditee’s premises for audits cond...
While the total number of the most serious medical device recalls in the US has declined in recent years, the number of recall events has steadily increased, according to data from the Food and Drug Administration (FDA).
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
The US Food and Drug Administration (FDA) warned Indian generic drugmaker Glenmark Pharmaceuticals Limited for several good manufacturing practice (GMP) violations observed during an inspection of its Goa, India facility last May.
Quality regulatory writing is the foundation of successful regulatory work. Regulatory professionals must communicate effectively and efficiently to convey complex concepts within tight timelines. The strength and purpose displayed ...
In its review, Medsafe’s committee considered TGA’s rationale and the evidence behind the decision. The review also looked at regulatory advice from Medsafe and the Medicinal Cannabis Agency and five comments it received after announcing the topic...
The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing. In the final version of guidance, ICH acceded to industry’s request to clarify ...
The European Medicines Agency (EMA) has recommended that pholcodine-containing drugs be pulled from the European market after its experts agreed there was a significant risk of allergic reaction to neuromuscular blocking agents (NMBA). The recomme...
Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars that have been introduced in the US recently had a stronger uptake than products ...
The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies (BE) for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug...
The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior...
The Swiss parliament has asked the country’s Federal Council to adapt its laws to allow medical devices that have been vetted by non-European regulators, such as the US Food and Drug Administration (FDA) to be marketed in Switzerland. Currently, o...