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FDA North America

August 26, 2022

FDA Announces Availability of Multiple Draft Guidances - Drug Information Update

Today, FDA announced the availability of the following draft guidances for industry, which were prepared under the support of the International Council for Harmonisation of Technical Requirements for...

FDA North America

August 25, 2022

FDA - Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies

FDA - Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. August 2022 This final guidance is intended to help applicants (or “you”) design and...

EMA Europe

August 23, 2022

EMA: Monkeypox

The European Medicines Agency (EMA) is supporting the European Union's (EU) response to the monkeypox outbreak. It is in close contact with medicine developers and its partner organisations in the...

FDA North America

August 22, 2022

FDA Issues Revised Draft Guidance on Charging for Investigational Drugs Under an Investigational New Drug Application

August 2022 Draft Guidance This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on...

FDA North America

August 17, 2022

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions

Draft Guidance for Industry and Food and Drug Administration Staff AUGUST 2022 FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care...

FDA North America

August 16, 2022

FDA Issues Over-the-Counter Hearing Aids Final Rule and Guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products

Today, the U.S. Food and Drug Administration (FDA) issued a final rule: Establishing Over-the-Counter Hearing Aids to improve access to safe, effective, and affordable hearing aids for millions of...

North America IVD

August 16, 2022

Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices

GUIDANCE DOCUMENT - Guidance for Industry and FDA Staff AUGUST 2022 In 2003, FDA issued an updated guidance on the "Replacement Reagent and Instrument Family Policy" for in vitro diagnostic (IVD)...

CDER FDA

August 15, 2022

FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products

This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and...

EMA Europe

August 3, 2022

EMA: List of centrally authorised products requiring a notification of a change for update of annexes

August 2022 EMA Regulatory and Procedural Guideline Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing...