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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

EMA Recommends New Approaches To Characterize Toxicity Of Anticancer Drugs

The European Medicines Agency has outlined new approaches for collecting and reporting of safety data to help better understand the toxicity and tolerability profiles of anticancer medicines. The new recommendations are published in an updated guideline that will apply from April 2018.

Safety Regulation

No More 'Hidden' Facilities, US FDA Tells Generic Sponsors

Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.

Generic Drugs Review Pathway

US FDA Staff Slams Agency Hiring Policies In Report Ahead Of Public Meeting

Agency to discuss results of report, as well as pending 2018 pilot project designed to modernize its hiring practices.

FDA Leadership

FDA's NDA And BLA Approvals: Juluca

Original new drugs and biologics recently approved by US FDA.
Approvals Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Don't Sleep On DTC Compliance: FDA Dings Zolpimist Superiority Claim Vs Ambien

Warning letter objects to webpage and meeting exhibit material for excluding any risk information and suggesting mist formulation is superior to oral zolpidem products.

BioPharmaceutical Regulation
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Policy

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Latest From Policy

FTC Scrutiny Of Profit Seeking In Drug Supply Chain In Fact-Finding Mode

Agency hears from experts on whether PBMs and group purchasing organizations operate under misaligned incentives.

Pricing Debate Legal Issues

Alex Azar And The Return Of Republican-Style Price Negotiation

The nomination of a former drug industry executive to run HHS is obviously good news for the biopharma sector, but it does not mean that HHS will do nothing about drug prices. On the contrary, it may make some high-profile action against pricing outliers all but inevitable.

Pricing Debate Policy

Will HTA Bodies Accept Your Innovative Trial Design?

Innovative trial designs add a new layer of uncertainty for health technology appraisal bodies. They are likely to adapt to a changing environment, but there could be a price for companies.

Clinical Trials Drug Approval Standards

Are Outcomes-Based Managed Entry Agreements Dead In Europe?

Outcomes-based managed entry agreements designed to help ensure access to expensive new medicines are not sustainable and have so far failed to provide a solution to the problem of funding costly innovative drugs, according to Ad Schuurman from ZIN, the Dutch National Healthcare Institute.

Pricing Strategies Market Access

Part D Proposal Aims To Promote Biosimilars, Generics To Reduce Costs

Medicare Part D proposed rule would lower cost sharing for biosimilars to the level of generics for some beneficiaries, allow immediate generic substitution for plans.

Medicare Biosimilars

What Is Inter Partes Review?

A description of the patent challenge proceeding and how it differs from district court litigation.

Intellectual Property Legal Issues
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