The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released a revised guide for inspectors and the pharmaceutical industry outlining the general principles of qualification and validation ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
This Week at FDA: FDA names acting CBER director, House committee advances FDA budget bill, and more
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 Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory authorities. Previously, Indian law permitted ...
The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to ...
The US Food and Drug Administration recently issued warning letters to an over-the-counter (OTC) drugmaker in India for ...
The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary ...
The US Food and Drug Administration (FDA) is seeking stakeholder feedback to create a Quantitative Medicine Innovation ...
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 (FDA) has published two guidances on transdermal or topical delivery systems (TDS) for generic drugs, including a final guidance on assessing adhesives for TDS ...
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