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FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA?s policies for issuing waivers, refunds, or reductions in prescription drug user fees. The newly issued guidance is a revision of a 1993 guidance titled Draft Interim Guidance Document for Waivers of and Reductions in User Fees.

The latest meeting of EMA?s Committee for Medicinal Products for Human Use (CHMP) has concluded with more than 15 positive opinions for new and generic drugs. Among other important announcements, the agency released a range of concept papers and guidelines for consultation and announced a safety review of orlistat-containing medicines.

Last week, FDA published a guidance titled Marketed Unapproved Drugs?Compliance Policy Guide, which describes the agency?s enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter (OTC) drug review. The document is a revision of the June 2006 guidance of the same name

FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement on Sept. 9, 2011, aimed at a stakeholder meeting held at the US Department of Health and Human Services (HHS) to address the growing problem of drug shortages in the United States. The shortages affect many necessary drugs, including those for cancer, anesthesia, influenza, and other critical conditions.

The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission?s 2010 amended pharmacovigilance legislation.

Novo Nordisk announced the roll-out of its Changing Diabetes in Children program in India, making India the seventh country to participate. The aim of the program is to contribute to meeting the fourth UN Millennium Goal?to reduce child mortality?by breaking down the barriers that prevent children with Type I diabetes in developing countries from receiving proper care. The program is currently operating in six countries?Bangladesh, Cameroon, the Democratic Republic of the Congo (DRC), Guinea, Tanzania, and Uganda, and Novo Nordisk plans to launch the program in Kenya within the next few months.

The International Society for Pharmaceutical Engineering (ISPE) will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide, ISPE Baseline Guide: Sterile-Product Manufacturing Facilities, and contain practical information about technological advances in sterile manufacturing.

The UK?s Technology Strategy Board has partnered with the Engineering and Physical Sciences Research Council (EPSRC) to invest as mush as £9 million ($14.2 million) in grant funding with the aim of bringing proof-of-concept ideas to pilot technology demonstration for healthcare.

Sanofi outlined its long-term financial objectives this week as the company discussed its strategy in mitigating generic-drug incursion and in generating growth in key therapeutic areas and emerging markets.

Pfizer has completed its cash tender offer for the biopharmaceutical company Icagen (Durham, North Carolina) after extending its initial deadline twice. The tender offer of $6 per share was originally scheduled to expire on Aug. 31, 2011, but had to be extended on both Sept. 1 and Sept. 2 after insufficient shares were tendered.

FDA?s Division of Drug Marketing, Advertising, and Communication (DDMAC) issued a letter to Pfizer?s vice-president of US Regulatory Affairs regarding its online resources page for Lipitor (atorvastatin calcium) tablets. The letter, which was brought about as part of the agency?s Bad Ad program, cites that the webpage is misleading because it makes representations and/or suggestions about the efficacy of Caduet (amlodipine besylate/atorvastatin calcium) tablets, Chantix (varenicline) tablets, and Norvasc (amlodipine besylate) tablets without communicating risk information associated with the use of these drugs.

EMA announced in a press release that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011. The new criteria (version 3.1) have been agreed with the regulatory authorities in European Union member states and will be applied to all electronic common technical document (eCTD) sequences received starting September 1.

The US Pharmacopeia (USP) continues to expand its collaboration with drug authorities around the world, this time with Brazil?s regulatory agency. USP and the Brazilian National Agency of Sanitary Surveillance (ANVISA) are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil, according to news releases on the USP website.

Bayer Healthcare has pledged its support to a Tuberculosis (TB) partnership by providing 620,000 tablets of the antibiotic moxifloxacin to the World Health Organization (WHO), which will make the tablets available to China?s national TB program. In particular, the medicine will be used to fight multidrug-resistant TB.

Since China?s State Food and Drug Administration (SFDA) revised its GMPs last year (they became effective Mar. 1, 2011), the agency has been making other improvements to enhance the quality of its pharmaceutical manufacturing industry. Many improvements are tied to the 2015 deadline SFDA has placed on existing domestic drug manufacturers to implement the revised guidelines. Newly created companies are expected to meet the new GMPs from the start.

In its latest filing with the Securities and Exchange Commission (SEC) for the quarter ending July 2011, Pfizer indicated that it has voluntarily provided the SEC and the Department of Justice (DOJ) with information concerning potentially improper payments made by Pfizer and Wyeth in connection with sales activities that took place outside of the United States.

The second quarter of 2011 presented a mixed picture of financing for the life-science sector, which includes the biotechnology and medical-device industries. Although venture-capital funding for the sector as a whole showed strong improvement, biotechnology investing dropped in terms of overall dollars invested and number of deals.

EMA has concluded in a recent report that a pilot program investigating the mutual benefits of joint international inspections of API manufacturing facilities has been a success. The collaboration between the EMA, a number of European member states, FDA, and Australia?s Therapeutic Goods Administration (TGA) sought to increase international regulatory information-sharing to enhance global drug quality and safety by building on API GMP standards.

Pfizer has partnered with the University of California?s San Diego Health Sciences (UCSD) in a drug-discovery collaboration that could see Pfizer invest up to $50 million over the next five years in the development of new therapies. The partnership will leverage UCSD?s expertise in neurosciences, cancer, inflammation, metabolism, clinical pharmacology, HIV, and pain.

FDA scientists published an article in the Aug. 4, 2011, issue of The New England Journal of Medicine that describes their current thinking about a pathway for the regulatory approval of biosimilars. The agency?s approach reflects its examination of EMA guidelines, as well as the nature of biological drugs.

In late July, FDA announced the 2012 user fees collected under the Prescription Drug User Fee Act (PDUFA) of 2007. The act stipulates that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of three categories: applications for approval of drug and biological products, establishments where the products are made, and drug and biological products. In some instances, the fees can be waived, reduced, or refunded, as spelled out in an FDA draft guidance issued in March 2011.

Last week, Merck & Co. unveiled plans to reduce its global workforce, as measured by year-end 2009 levels, by an additional 12–13% by 2015. The company described its plans in its report on second-quarter earnings, which the company issued on July 29, 2011.

Last week, the International Society for Pharmaceutical Engineering (ISPE) published a guidance document titled ISPE Good Practice Guide: Process Gases. The guide defines current best practices in pharmaceutical manufacturing applications for handling gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams (e.g., nitrogen, oxygen, argon, carbon dioxide, and compressed air).

The European Medicines Agency has updated the template for package leaflets to make the information easier for patients to understand. Leaflets will now include less rigid language and new sections that provide greater information about a drug?s benefits. There will also be more information about the medicine?s use in children to comply with the requirements of pediatric regulation.

Bristol-Myers Squibb (BMS) has signed an agreement to acquire Amira Pharmaceuticals, a small-molecule company with a focus on treatments for inflammatory and fibrotic diseases for $325 million. The amount will be paid upfront, but there is potential for additional milestone payments up to $150 million. The acquisition represents BMS?s entrance into the fibrotic diseases area, which the company says is an area of high unmet need.

The age of globalized industry should result in fewer barriers between countries, but it is rarely that straightforward in practice. At the India?US Strategic Dialogue held in New Dehli on July 19, 2011, India?s junior science minister Ashwani Kumar complained to US presidential science adviser John Holdren that a new US visa policy is hampering the ability of Indian scientists to travel to the United States, according to a report by ScienceInsider. Kumar asked that the procedure be streamlined. Indian scientists, even top aides to the government, are now required to renew their visa annually, but they previously could obtain a multiple-entry visa every 5 to 10 years. This change makes it difficult for Indian scientists to attend conferences in the US or engage in any other frequent, short-duration travel without attending to yearly paperwork. ?I understand the visa issue is a problem and a challenge, and we hope to improve it,? said Holdren, according to ScienceInsider.

FDA released this week a report from its Center for Drug Evaluation and Research (CDER) that identifies regulatory science needs that will guide CDER?s strategic planning in the years ahead and allow it to fulfill its regulatory mission. The report, Identifying CDER?s Science and Research Needs, discusses internal research initiatives and goals for contributing to the agency?s overall regulatory science efforts.

The global production of seasonal influenza vaccine will double to 1.7 billion doses by 2015, according to a presentation given by Marie-Paule Kieny, the World Health Organization?s (WHO) assistant director general for innovation, information, evidence, and research. Kieny spoke at the WHO?s first review of its Global Action Plan (GAP) for Influenza Vaccines on July 12?14, 2011. New manufacturers in 11 developing countries, including Brazil, India, Iran, Mexico, and Vietnam, will be producing vaccines by that time, according to the presentation.

The negotiations under way to control government spending and reduce the deficit have the potential to impact pharmaceutical revenues. A proposal is on the table to increase drug rebates under Medicare Part D as a means of controlling the overall costs of the Medicare program. The Pharmaceutical Research and Manufacturers of America (PhRMA) is opposed to such measures, concerned that a decrease in revenues could damage a healthy and growing industry and that the ripple-effects from a slowdown in biopharmaceutical growth could negatively impact an already fragile economy. In a press release, PhRMA president and CEO John J. Castellani issued the following statement:

In early July 2011, FDA provided an update in which the agency said that it has made progress toward implementing the US Food Safety Modernization Act (FSMA), which was enacted in January 2011. In addition to clarifying expectations for new dietary ingredients through new draft guidance, the agency has issued an antismuggling strategy.