International – ICH guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH...

ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral...

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...

Europe – Actions to support the development of medicines for children

Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and...

Europe – Public consultation on a multi-stakeholder platform to improve clinical trials in the...

On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment 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...
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications

USA – FDA draft guidance addresses clinical development of drugs to treat early Lyme...

The US Food and Drug Administration (FDA) Center for Drug Evaluation Research (CDER) has issued a draft guidance to help sponsors develop new drugs...

USA – FDA draft guidance addresses use of external controls to assess effectiveness of...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Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors...

UK – Roche’s Polivy recommended by NICE for lymphoma therapy

In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated diffuse...

USA – FDA issues draft guidance on developing drugs for acromegaly

The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors develop acromegaly treatments for patients who have either not...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)...