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Combo Product Classification Guidance Doesn't Fix All Existing Problems, Experts Say

US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.

Review Pathway FDA

Pharma’s ‘No-Show’ At Regulatory Meetings In India: Who Loses?

Regulators in India routinely face flak over lengthy approval timelines, but drug firms failing to show up at pre-scheduled regulatory meetings does little to improve the situation. The reason for the no-shows is open to speculation. Absenteeism appears to be significant in areas such as oncology and hematology.

Regulation Review Pathway

US Filing For AZ’s Imfinzi In Stage III Lung Cancer

Important US filing goes ahead as AstraZeneca submits sBLA for Imfinzi in earlier-stage non-small cell lung cancer.

United States Drug Review

Keytruda's New Tissue-Agnostic Indication Could Prompt Orphan Policy Changes

US FDA contemplating how to match orphan designation process with drug development moving to molecularly-targeted therapies.

Rare Diseases Review Pathway

China Innovation Policy Reform Streamlines Trial Management

China's latest initiative to establish an innovation ecosystem replaces clinical trial site pre-certification with registration; also included are provisions allowing use of foreign data, strengthening data protection and providing conditional approvals of rare disease treatments.

China Clinical Trials

Half Of All EU Fast-Track Requests Fail; AZ’s Imfinzi Among Latest

The European Medicines Agency recently denied AstraZeneca’s pre-filing request for accelerated assessment of Imfinzi in Stage III NSCLC, an indication the company is hoping to make its own. It’ll be no consolation that the EMA this year seems to have rejected as many fast-track requests as it has granted.

Europe Review Pathway

Real-World Evidence: Advice, Principles And Examples Emerge From FDA

Biopharma sponsors are eagerly awaiting guidance on how to apply 'real-world evidence' to drug development and regulatory decisions. Recent workshops provide some clues about what is likely to be included in the first drafts.

Review Pathway Clinical Trials

Mechanism-Based Drug Rejection? Ataluren’s Unlikely Personalized Medicine Milestone

US FDA has shown it can be very flexible in expanding indications for a targeted therapy with a clearly established mechanism of action. But, as PTC Therapeutics learned, the agency’s willingness to apply mechanistic knowledge for targeted therapies cuts both ways.

Rare Diseases Drug Approval Standards

FDA Rolls Out Zero-Tolerance Policy On ANDA Typos

In another show of force on generic drug application quality, US agency says it will not accept applications with major deficiencies caused by a typographical error, even if the sponsor corrects it.

Generic Drugs Review Pathway
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