USA – CBER chief on remote work, CRISPR-Cas9, and rare disease gene therapy accelerated...
The use of CRISPR-Cas9 gene editing technology has potential to transform the field of gene therapy through its simple and cost-effective delivery mechanism, said...
USA – FDA updates policies for reviewing ANDAs
The US Food and Drug Administration (FDA) has revised its manual of policies and procedures (MAPP) for conducting a filing review of an abbreviated...
USA – FDA offers first guidance on stimulant use disorder drug development
The US Food and Drug Administration (FDA) has published a draft guidance that for the first time offers recommendations for drug development and clinical...
USA – Convergence: Psychedelic drug development is ‘hot,’ but proceed with caution
Psychedelic drug development is receiving more attention lately as these treatments offer the potential for needed therapeutic alternatives for various mental health conditions, yet...
USA – Convergence: FDA looking for ‘a new way forward’ on CBD regulation
The US Food and Drug Administration (FDA) is open to developing a new regulatory framework for cannabidiol (CBD), according to an agency official who...
Latin America – Brazil, Mexico launch efforts to ease biosimilar regulation
In recent weeks, both Brazilian and Mexican regulatory authorities have made public their eagerness to spur domestic production – and faster regulation – of...
USA – FDA issues guidance on assessing quality of topical ophthalmic drugs
The US Food and Drug Administration (FDA) issued new draft guidance recommending a battery of studies that manufacturers should use to assess the quality...
USA – FDA offers guidance on development of antimicrobials for diabetic foot infections
The US Food and Drug Administration (FDA) released new draft guidance on developing antimicrobial drugs specifically intended to treat diabetic foot infection, a focused...
France – FDA guidance calls for testing all alcohol-based products for methanol
The US Food and Drug Administration (FDA) issued final guidance to assist manufacturers and compounders in testing alcohol products (ethanol and isopropyl) for methanol....
USA – FDA finalizes guidance on considerations for evaluating drug’s benefits and risks
The US Food and Drug Administration (FDA) has finalized guidance that clarifies how the benefits and risks of a drug or biologic factored into...
