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Set Alert for Global

International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine

A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.

International Coronavirus COVID-19

UK Reveals Seven Partners Whose New Drug Approvals It Will Recognize

The UK regulator, the MHRA, says that while it will recognize drug approvals granted in the EU and a selection of other countries, it will remain a “sovereign regulator” with the ability to reject applications if they don’t meet its standards.

Europe United Kingdom

ICH Consults On Modernized GCP Principles To Make Clinical Trials More Efficient

The International Council for Harmonisation has issued updated Good Clinical Practice principles to accommodate new clinical trial and data types.

International Clinical Trials

UK Offers Fresh Funding For New Drugs & Vaccines Against AMR

New funding from the UK’s antimicrobial resistance innovation fund is to be welcomed, but the UK pharmaceutical industry body, the ABPI, has cautioned that “multiple global solutions” bringing together governments, health care systems and the industry are needed if research efforts are to result in effective new antibiotics.

Europe United Kingdom

Quotable: Top Experts On Policy Hot Topics

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Clinical Trials Health Technology Assessment

New Project To Develop Consensus-Based Outcomes For Trials Targeting Rare Skin Condition

An international project that aims to develop a harmonized framework on the minimum aspects that should be measured and reported in clinical trials for the genetic skin disorder, epidermolysis bullosa, has drawn the European Medicines Agency’s attention.

International Europe

EU Regulators Lift Temporary COVID-19 Measures But Resources Remain An Issue

The European Medicines Agency said that while the temporary measures that were introduced to cope with the peak impact of the COVID-19 pandemic were no longer required, “resourcing within the entire European medicines regulatory network remains a challenge.”

Europe International

First OTC Oral Contraceptive Has Advisory Panel’s Unanimous Support Despite FDA’s Data Concerns

FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before advisory panel voted at close of a two-day meeting conducted 60 years after first Rx oral contraceptive approved in US.

FDA Drug Approval Standards

Global Pharma Guidance Tracker – April 2023

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation

International Off-Patent Industry's Wishlist For WHO Pandemic Accord

As the WHO seeks input on a global accord to strengthen pandemic preparedness, the IGBA has provided suggestions from the off-patent industry ahead of a key step in the drafting process later this month.

Supply Chain International

EU Platform Trials Project Piques WHO’s Interest

The World Health Organization is developing a new best practice guideline on improving the quality and efficiency of clinical trials and is keen to learn what role platform trials can play on this front and their acceptability by the clinical trial community.

Europe International

US Smoking Cessation Clinical Trials Guidance ‘Does Not Envision’ Flexibility On Indications

FDA final guidance maintains limit on secondary endpoints allowed for trials, which could dissuade some investment in research for NDAs for smoking cessation products. NRT developers could find more room for novel product proposals from changes to some phrasing.

Guidance Documents OTC Drugs
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