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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

Purdue's Butrans: US FDA Panel To Consider Pediatric Labeling, But Not A New Indication

Purdue says it conducted a trial required under the Pediatric Research Equity Act but is not seeking a formal indication and will not promote the opioid for pediatric populations. Two advisory committees will discuss the trial results and whether they support additional labeling for the buprenorphine transdermal product Sept. 13.

Advisory Committees Pediatrics

More Questions As Biocon Pulls EU Filings For Two Biosimilars

Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.

Biosimilars Manufacturing

Pharma Requests Pilot To Test Public Value Of EU Guide On Plain Language Summaries

The European pharmaceutical trade group EFPIA says an “initial pilot” program should be launched to test the value and impact of the draft EU guideline on presenting lay summaries of clinical trial results. The group believes that the guideline should be reviewed following the pilot, as complying with it in its current form would result in companies shelling out “significant additional resources.”

Clinical Trials Regulation

EU Member States Taking New Steps To Tackle Drug Shortages

The EU Heads of Medicines Agencies has outlined some of the recent initiatives taken by the member states to deal with medicines shortages, including a new Dutch center and a member state coordinating initiative by the Irish regulator.

Distribution Manufacturing

Consumer Health Weekly Trademark Review Aug. 8, 2017

Ccompiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

Consumer Trademarks

GMP Problems Stop Canadian Firms’ Topical OTC, Homeopathic Imports

Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.

Consumer Manufacturing
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Policy

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Latest From Policy

Par Alleges 'Shocking' Trade Secret Theft By QuVa Pharma

Par says former employees who founded QuVa used Par's trade secrets to develop a vasopressin product, which FDA has added to its list of ingredients for drug compounding.

Intellectual Property Policy

White House Advisor Philipson Brings Industry-Aligned Views On Drug Value

Tomas Philipson, a University of Chicago professor and consultant to the pharmaceutical industry, is named to the White House Council of Economic Advisors.

Appointments Pricing Debate

Korea's Reimbursement Steps Spark Drug Price Cut Concerns

In its first announcement of major health care measures since the Moon Jae-in administration took charge, South Korea unveils steps to hike its national health insurance coverage ratio to levels in advanced countries, raising concerns that this might lead to sharp drug price cuts.

Policy Reimbursement

Pooled Purchasing Is Poor Answer To Latin American Drug Pricing Worries, Says Industry

Pooled procurement will not fix problems relating to affordability and access to medicines in South America, says the US pharma industry association, PhRMA, in response to news that Mercosur trade bloc members will join forces to negotiate better prices for medicines.

BioPharmaceutical Emerging Markets

More European Countries Agree To Swap Pricing Info And Negotiate Prices

Another alliance among EU countries to tackle high medicines prices is gathering pace. Eight countries are to soon start swapping pricing information and have agreed to join forces to negotiate more affordable prices.

Market Access Policy

Biogen Ventures Into Value-Based Contracts In Multiple Sclerosis

Four contracts test approaches tying reimbursement to relapse rates and discontinuation of treatment. Payers involved include Harvard Pilgrim and Intermountain's SelectHealth.

Reimbursement Pricing Strategies
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