RAPS

Why FDA finds Form 483 responses inadequate

FDA looks for evidence behind the corrective action Many companies recalled product, opened corrective and preventive actions (CAPAs), revised procedures, submitted records, or wrote to FDA more than ...
Regulatory Affairs Professionals Society

Convergence: Regulators highlight efforts to streamline the European regulatory framework

A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help ...
RAPS

HHS launches ARPA-H project to speed clinical trials

The US Department of Health and Human Services on Wednesday announced a program and funding opportunity through the Advanced Research Projects Agency for Health (ARPA-H) called the ...
RAPS

Recon: FDA approves drugs for Parkinson’s, bile duct cancer, rare soft tissue disease; Merck, Daiichi scrap application for ADC in lung cancer

Food & Nutrition FDA warns three Northeast food importers about missing supplier verification programs (Food Safety News) Testing finds widespread microplastics, lower heavy metals in baby foods (Food ...
RAPS

FDA call for new adcomm members signals renewed interest in outside advisors

The US Food and Drug Administration (FDA) has issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the role of FDA ...
RAPS

AI in regulatory writing: Examining critical pitfalls and implications

AI is increasingly being used in the preparation of regulatory documents. Sponsors are adopting AI-driven tools to generate summaries, rephrase standard content, and assist with drafting across a ...
RAPS

FDA draft guidance addresses considerations for robotically assisted surgical devices

The US Food and Drug Administration (FDA) published a draft guidance detailing its thinking on the requirements for bringing certain robotically assisted surgical devices (RASD) to market. It includes ...
RAPS

Asia-Pacific Roundup: Indian government approves adverse event monitoring plan for transplantation products

The Indian government has approved a program for monitoring adverse events associated with medicines and biological products used in organ and tissue transplantation. Hailed by the government as a ...
RAPS

Single pivotal trials: Stakeholders seek definitions, clarification about evidentiary standard

Industry groups and other stakeholders are generally supportive of FDA’s recent draft guidance explaining when single pivotal trials plus confirmatory evidence can be used to support the approval of ...
RAPS

Convergence: CBER expert offers tips for effective BLA submissions

CHARLOTTE, NC — When submitting a biologics license application (BLA), it is important to engage with the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) early, make every ...