2+ day, 3+ hour ago   (513+ words) The Office of Management and Budget received a final rule to review on the development of cell and gene therapies. The rule would serve as a document that answers common questions industry stakeholders may encounter when developing these products involving…...

2+ day, 23+ hour ago   (657+ words) RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about…...

2+ day, 22+ hour ago   (921+ words) A trade group has asked European authorities to give notified bodies access to the Eudamed database to empower them to deliver the risk-based oversight proposed in the pending medtech regulatory reforms. Seeking to simplify the rules on medical devices and…...

3+ day, 4+ hour ago   (185+ words) RAPS has announced the names of the 146 professionals who earned their Regulatory Affairs Certification (RAC) credentials in the spring 2026 exam window. The RAC is the leading credential for regulatory professionals who work in the healthcare products sector. There are two…...

2+ day, 23+ hour ago   (304+ words) RAPS Your choice regarding cookies on this site - Recon: FDA grants Concerta generic withdrawal hearing; Ivonescimab wins first-line NSCLC nod in China Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. - FDA grants hearing on Lannett generic Concerta withdrawal…...

4+ day, 22+ hour ago   (303+ words) Its purpose is to guide inspectors and the pharmaceutical industry by promoting medicinal quality assurance through a validation program compliant with good manufacturing practice (GMP). The guideline will take effect on 1 October and replaces a previous guideline that was implemented…...

5+ day, 22+ hour ago   (799+ words) The Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory authorities. Previously, Indian law permitted authorities to reject applications featuring misleading, fake, or fabricated documents and to cancel the applicant’s existing…...

5+ day, 22+ hour ago   (332+ words) raps.org - Recon: BMS plans $2.3B Houston manufacturing site; MHRA approves Lilly weight-loss drug for weight loss, type 2 diabetes Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. - Replimune melanoma drug snags coveted FDA approval after yearlong clash, two rejections…...

1+ week, 1+ day ago   (470+ words) FDA will host a virtual workshop on 23 September on using next-generation sequencing tests to detect adventitious agents AA in biologics. The agency notes that the technology has emerged as a new approach methodology (NAM) that can significantly improve the safety…...

1+ week, 3+ day ago   (398+ words) raps.org - Recon: FDA approves first drug for type 1 narcolepsy, mRNA flu vaccine; No merger talks between AstraZeneca-BMS Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing....