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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog: Biosimilars

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Now, guidances are generally not legally binding, unlike statutes or regulations. FDA Guidance , at 8 (emphasis added). If so, please call us.)

FDA 105
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Article Periodic: EU’s PIC Regulation adds 35 new entries

Agency IQ

EU’s PIC Regulation adds 35 new entries The European Commission’s latest update to the export and import of hazardous chemicals regulation – which implements the Rotterdam Convention on prior informed consent in the EU – includes 27 pesticides and eight industrial chemicals in the list of substances requiring export notification.

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Article Periodic Thank You EU’s PIC Regulation adds 35 new entries

Agency IQ

EU’s PIC Regulation adds 35 new entries The European Commission’s latest update to the export and import of hazardous chemicals regulation – which implements the Rotterdam Convention on prior informed consent in the EU – includes 27 pesticides and eight industrial chemicals in the list of substances requiring export notification.

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Article Periodic: France finds unclear disinfectant labeling to blame for chemical burns in children

Agency IQ

It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products. Regulatory background Biocides are regulated primarily by the Biocidal Products Regulation (BPR) (528/2012/EU).

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Article EMA Thank You British regulators tease new device regulations in informative live session

Agency IQ

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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Article EMA Thank You What we expect European regulators to do in May 2024

Agency IQ

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Analysis Chemical Thank You What we expect EU chemical regulators to do in August 2024

Agency IQ

What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.