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Policy & Regulation

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US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews

The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.

Drug Review Profile Review Pathway Drug Review

Bids For EMA Show East-West Split Over Principle of Fair Spread Of Agencies

Some countries in eastern Europe say that they should host the European Medicines Agency in order to respect the criterion of “geographical spread.” But many in western Europe say this principle should apply only to new agencies and that the criterion of business continuity at the EMA should take precedence.

Brexit Europe Regulation
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Regulation

Set Alert for Regulation

Latest From Regulation

New ICH Guide To Eliminate ‘Discordant Advice’ On Juvenile Animal Studies

Experts at the International Council for Harmonisation have nearly completed the first draft of a guideline that explains in which situations nonclinical juvenile animal testing is considered informative and necessary to support pediatric drug development. The guideline is expected to address the "discordant advice" that different regulatory agencies currently offer companies in relation to such studies.

Safety Clinical Trials

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

FDA Search For CDER Deputy Emphasizes 'Executive Direction'

An M.D. is preferred for position that would run CDER in director's absence and oversee 'major programs' at the Center.

FDA Leadership

Moscicki's Move From FDA To PhRMA About 'Best' Use Of Leadership Skills

At inconveniently timed NORD conference, the former CDER deputy center director finds himself unable to speak for either FDA or the Pharmaceutical Research and Manufacturers of America.

FDA Leadership

Semaglutide Retinopathy Risk No Bar To Approval, US Panel Says

Novo Nordisk's once-weekly GLP-1 agonist can address diabetic retinopathy complications through labeling, US FDA advisory committee says in endorsing approval; panelists say a postmarketing study on retinopathy would be desirable and could be folded into a larger cardiovascular outcomes trial.

Advisory Committees Drug Review

Consultation To Help Determine Whether EU SPC Framework Fit For Purpose

The European Commission has launched a consultation on proposals to “recalibrate” supplementary protection certificates and patent research exemptions.

Europe Biosimilars
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Policy

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Latest From Policy

Drug Pricing Legislation Appears Nowhere In Sight Following Senate Hearing

Senators and witnesses rehashed years-old arguments and found little common ground on which elements of drug pricing to address.

Pricing Debate Reimbursement

Antibiotic Incentives: Prize Fund Is Focus Of Presidential Report On Incentives

Upcoming White House report on antibiotic incentives will provide a strong endorsement of one-time payments to reward successful development of new therapeutics. That is a mixed blessing for advocates for legislative action for incentives who are focusing on 'wildcard' patents.

Infectious Diseases Intellectual Property

Allergan May Rue Mohawk Tribe Deal As Court Invalidates Restasis Patents

District court questions legitimacy of Allergan's patent transfer tactic, saying it 'could spell the end of the PTO's IPR program.'

Intellectual Property Policy

Pfizer Takes On International Reference Pricing

Sam Taylor, Pfizer’s head of global pricing, shares his wisdom on the increasingly complex subject of international reference pricing.

Pricing Strategies Pricing Debate

Opioid Abuse: The Limits Of Industry’s Response

PhRMA is endorsing dispensing limits on opioids and pledging to support a public/private partnership to develop new treatments and alternatives. But members of a Presidential Commission didn’t seem impressed.

Advertising, Marketing & Sales Policy

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
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