USA – DSCSA: New interoperability ‘blueprint’ released
With less than a year remaining before the Drug Supply Chain Security Act (DSCSA) takes full effect, an industry consortium has published new chapters of a...
USA – FDA releases FY 2022 generic drug research summary
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year...
USA – FDA draft guidance addresses clinical development of drugs to treat early Lyme...
The US Food and Drug Administration (FDA) Center for Drug Evaluation Research (CDER) has issued a draft guidance to help sponsors develop new drugs...
USA – FDA draft guidance addresses use of external controls to assess effectiveness of...
The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors...
USA – FDA issues draft guidance on developing drugs for acromegaly
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors develop acromegaly treatments for patients who have either not...
USA – Experts offer CTIS advice on eve of transition for new applications
Many pharmaceutical companies in the EU are waiting on the sidelines to submit new clinical trial applications to the Clinical Trial Information System (CTIS)...
USA – FDA pulls Evusheld authorization as coronavirus evolution quashes another therapy
The evolution of the coronavirus has knocked out another treatment.
The Food and Drug Administration on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to...
USA – FDA finalizes guidance on cannabis clinical research
The US Food and Drug Administration has finalized a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs...
USA – FDA officials impart lessons learned from quality management maturity pilots
The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or...
USA – FDA issues draft guidance on mpox drug development
In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot...
