This White Paper establishes the position of the Pharmaceutical Research and Manufacturers of America PhRMA on the use of electronic authentication technologies, such as two-dimensional bar codes and radio-frequency identification RFID tags, to secure the U.S. drug supply against counterfeiting threats. PhRMA issues this White Paper to engage patients, trading...
BROAD RESEARCH mandated by the Medicare Modernization Act has been unfairly narrowed to the comparative effectiveness of prescription drugs due to interest in the Medicare prescription drug benefit, according to recent comments from the Pharmaceutical Research and Manufacturers of America PhRMA.
While full implementation of an RFID/EPC system to track and trace pharmaceutical products from manufacturer to the pharmacy may be some years away, federal regulators and industry leaders alike believe the technology offers the best weapon in the While full implementation of an...
FDA review of all clinical study data supporting drug approvals is a protective shield against conflicts of interest in industrysupported medical research, according to the Pharmaceutical Manufacturers and Research of America PhRMA in response to a health policy report in the May 18 issue of the New England journal of...
The increased potential for unblinding makes the FDAs "blanket requirement" for real-time data analysis unnecessary in the agency's Draft Guidance for Industry on Population Pharmacokinetics, writes PhRMA Vice President John D. Siegfried in comments to the agency. "Most sponsors would tolerate a delay in availability of results from a population...
PhRMA and BIO oppose legislation aimed at weakening pharmaceutical prices. INDUSTRY OFFICIALS are expressing strong opposition to new legislation that would prevent US pharmaceutical and biotechnology companies from selling prescription drugs PhRMA and BIO oppose legislation aimed at...
THE GENERIC DRUG industry's lawsuit against Food and Drug Administration to halt implementation of a pediatric testing program would be a major setback for sick children, the Pharmaceutical Research and Manufacturers Association says in papers rece THE GENERIC DRUG industry's lawsuit against Food and...
The FDA is considering revising its new policy against multiple trademarks for the same chemical entity, in response to criticisms from PhRMA, the agency's associate director for drug safety, Jerry Phillips, stated. Up until April of 2001, the FDA had allowed the use of multiple trademarks by drug sponsors, but...
THE PHARMACEUTICAL industry is fighting Senate legislation that would allow prescription drugs to be imported from Canada and other countries where brand-name medicines are generally sold at lower prices than in the US. The Pharmaceutical Res THE PHARMACEUTICAL...
' The FDA's willingness to collaborate with industry in the implementation of the FDA Modernization Act doesn't go nearly far enough to please the medical device industry's Health Industry Manufacturers Association HIMA, but it's just fine by the drug industry's Pharmaceutical Manufacturers and Research of America PhRMA. HIMA President Alan...
CONGRESS TOOK major steps last week toward approval of a $400 billion, 10-year plan that would offer some prescription drug coverage to America's 40 million Medicare beneficiaries. The full Senate began debating the legislation after the measu CONGRESS TOOK...
WHILE PHARMACEUTICAL manufacturers continue to oppose efforts to create a new Medicare drug benefit that could lead to price controls, the industry is also furiously lobbying against a more immediate concern: a drug-import provision in both the Hou WHILE PHARMACEUTICAL manufacturers continue to oppose...
HOUSE AND SENATE negotiators have tentatively agreed to allow US-made prescription drugs to be reimported from Canada, Mexico and other countries where they are usually sold at much lower prices, congressional sources said last week. The prop HOUSE...
DEMOCRATS COMPLAIN that an agreement reached between House and Senate negotiators to allow US-made prescription drugs to be reimported from foreign countries where they are usually sold at much lower prices has been effectively gutted by the pharma DEMOCRATS COMPLAIN that an agreement reached...
US RESEARCH-BASED pharmaceutical companies are expected to spend $20.6 billion to research and develop new drugs in 1998, a 10.7 percent increase over last year's investment, according to a survey of member companies conducted by the Pharmaceutical R US RESEARCH-BASED pharmaceutical companies are expected to spend...
THE BRAND-NAME pharmaceutical industry is praising Congress and Food and Drug Administration for implementing a major reform bill to streamline the drug approval process. The Food and Drug Administration Modernization Act of 1997 "affect THE BRAND-NAME pharmaceutical industry...
THE PHARMACEUTICAL industry plans to oppose changes to the regulatory process the Food and Drug Administration uses for switching prescription drags to over-the-counter OTC status, an industry trade group says. Russel Bantham, general couns THE PHARMACEUTICAL industry plans...
THE FOOD AND DRUG Administration's Center for Drug Evaluation and Research reviewed 199 new drug applications in 1998 and approved 90 of them, according to an FDA performance report. The average review time by the FDA department in 1998 was 12 ...
Public disclosure of information packages provided to advisory committee members prior to a panel meeting could jeopardize trade secret and confidential/ commercial information, industry argues in recently released comments to the FDA. The comments are in response to an agency draft guidance entitled Disclosing Information Provided to Advisory Committees ...,...
Byline: RUPAL PAREKH WASHINGTON-A long-awaited federal report has reignited the debate on prescription drug reimportation, contending that drugs from abroad now pose significant health risks, while a safer U.S. government-regulated importation pro Byline: RUPAL PAREKH WASHINGTON-A long-awaited federal report has...
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