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Policy & Regulation

Set Alert for Policy & Regulation

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


Set Alert for Regulation

Latest From Regulation

Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

EU Drug Filings To Fall Slightly In 2019, But Scientific Advice On The Up

The EMA expects initial applications for drug approvals to decline slightly next year, with the budget also down a little because of Brexit uncertainty. The agency's management board reported on its visit to the agency’s future home in Amsterdam. 
Drug Review Regulation

Two Orphans And An Avastin Biosimilar Among EU Approval Recommendations

Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP.  Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn its application for another.

Europe Regulation

New Russian Quality Assurance Rules Could Push Up Costs & Delay Product Launches

New rules aimed at tightening quality control on medicines that are to be introduced in Russia next year are expected to help prevent low-quality drugs getting to the market. However, they will bring some additional costs for pharmaceutical companies. It is also being suggested they could lead to delays in product launches.

Regulation Russian Federation

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

Has R&D Productivity Rebounded? US FDA Officials Think So

Record-setting pace of NME approvals is a cause for celebration. But is it a sign that drug industry R&D productivity has actually improved? The US FDA’s top drug review official thinks so – but the data aren’t yet clear.
Drug Review FDA
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Set Alert for Policy

Latest From Policy

Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus

US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.

Biosimilars Metabolic Disorders

UK Inquiry Into ‘Unfair’ Orkambi Pricing Risks Pricing Confidentiality

The UK government has criticized Vertex for the company’s approach to pricing its cystic fibrosis drug Orkambi. In the meantime, a parliamentary inquiry that could expose sensitive pricing details moves forward.

Europe United Kingdom

Infectious Diseases Proposed As Focus Of Inter-Korea Health Cooperation

Amid ongoing talks to denuclearize North Korea, the two Koreas are gearing up for bilateral cooperation in various industries including the health and medical sector, if and when international sanctions on the North are lifted. A new report suggests possible ways the two sides can initially work together in the area, with a focus on infectious diseases.

South Korea North Korea

Revamped Cancer Drugs Fund Means More Positive Recommendations, Says NICE

NICE, the health technology appraisal body for England and Wales, has rejected criticism that access to cancer drugs is worsening in the UK. The institute pointed to the revamped Cancer Drugs Fund which it said meant more positive recommendations.

Europe United Kingdom

Older Patents Get Help As Federal Circuit Sides With Novartis In Gilenya, Everolimus Disputes

US court finds no obviousness-type double patenting under statute that changed patent term from 17 years from issuance to 20 years from filing; decisions will impact other cases involving patents issued prior to statute.
Generic Drugs Legal Issues

Counter-Intuitive Thinking To Combat Drug Shortages

Search for solutions to chronic drug shortages may require policymakers to push for payment policies that run counter to the current drug pricing themes, like retrofitting US Medicare’s New Technology Add-On Payments to apply to old, off-patent therapies.
Generic Drugs Manufacturing
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