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Policy & Regulation

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Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA

But sponsors should sometimes seek advisory comment. Agency explains that most drug-use-related apps will be considered promotional labeling. FDA seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-focused software.

Digital Health Advertising, Marketing & Sales Regulation
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Regulation

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Latest From Regulation

Only One In Seven PRIME Applications Meet EMA Test

Of the 14 applications for entry onto the European Medicines Agency’s priority medicines scheme during the first two months of 2019, only two – from AstraZeneca and Freeline – made the grade.
Europe Market Access

ICH Consults On Guideline To Improve Bioanalytical Data Consistency

The finalization of a new international guideline that proposes a harmonized approach on bioanalytical method validation is expected to reduce the need for additional validation experiments and support streamlined global drug development.
International Regulation

Woodcock: Concerns About US FDA's Biosimilars Suffix Policy Detached From Reality

In an exclusive interview, Center for Drug Evaluation and Research Director Janet Woodcock contends that industry concerns about FDA's new suffix policy aren't reflective of real-world problems.
Biologics Biosimilars

Zulresso Postmarket Commitment Hints At Easier Dosing In Postpartum Depression

US FDA wants Sage Therapeutics to explore Zulresso use in alternative settings in a postmarketing trial. A successful study could expand access to the new approved brexanolone, whose administration is now long, complicated, and restricted to certified healthcare facilities.
Approvals Neurology

Canada Plans New Agency To Negotiate Drug Prices & Tackle Soaring Costs

A proposed new drugs agency with the power to evaluate the effectiveness of medicines and negotiate prices with manufacturers is seen as the first step towards a national pharmacare program offering universal drug coverage in Canada.
Pricing Debate Reimbursement

Saudi FDA Consults On Compassionate Use Program Requirements

The Saudi drug authority has clarified the roles and responsibilities of the various players involved with giving patients access to drugs under development on compassionate grounds.
Saudi Arabia Regulation
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Policy

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Latest From Policy

Health Technology Assessments And the Trouble With Rare Disease Treatments

To get their gene or cell therapies through health technology appraisals, companies need to agree to gather longer-term evidence, be upfront about what treatments can really deliver and remember to ask for patient input.

Europe Health Technology Assessment

Running The Gauntlet: Takeaways From The First Round Of HHS Hearings In 2019

Release of the White House budget proposal kicked off the first round of hearings on HHS with a new Democratic majority in the House and a new HHS budget czar in the Senate. HHS Secretary Azar did his best to set a constructive tone for advancing drug pricing policies – and maintaining his own position – in the year to come.  
Legislation Leadership

AbbVie's 'Unjustified' Humira Settlements Divide Market, Class Action Claims

First suit challenging biosimilar litigation settlements ratchets up pressure on AbbVie's "patent thicket" and licensing strategy.

BioPharmaceutical Biosimilars

Price ‘Anchoring’? Zolgensma And The Art Of Managing Gene Therapy Sticker Shock

Public statements by Novartis and AveXis suggest Zolgensma could be cost effective at a price up to $5m. Analysts expect $2m. The lower estimate is still stunning, but could it be considered reasonable by comparison?
Pricing Strategies Reimbursement

Measles Hearings Offer Counterpoint To Pricing Spotlight: Vaccines Touted As Cost-Effective Solution To Outbreaks

Congressional hearings on the recent outbreaks of measles and other vaccine-preventable diseases offered a positive theme for the industry during the ongoing drug pricing debate.

Legislation Drug Safety

Generics Firms Improved Chances Of Winning Pre-ANDA Meetings For Complex Drugs Last Year

FDA officials said manufacturers of complex generic drugs submitted more approvable requests for pre-submission meetings for FY 2018. Official also clarifies at recent meeting when it's best to request a pre-ANDA meeting and when to submit a controlled correspondence.

Manufacturing Quality
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