Exemptions

Outbreaks of Whooping Cough Contributed by Vaccine Exemptions

Outbreaks of whooping cough may be contributed by state laws which allow parents to exempt their child from vaccine due to personal beliefs according to researchers reported// Tuesday. Investigators found higher rates of whooping cough in such states to the tune of around 50 percent higher tha...

NACDS Urges Clarifications, Enhancements in Two Pharmacy Reimbursement Provisions in House Healthcare Reform Legislation

...escription medications. We applaud the inclusion of a limited exemption for pharmacies from accreditation and surety bond requirements. These narrow exemptions are consistent with efforts to curb fraud, waste, and abuse in the Medicare program, while at the same time protecting beneficiary access to these sup...

RNs Praise House Vote to Permit State Single-Payer Laws

...duced by Rep. Dennis Kucinich of Ohio, the amendment would remove potential legal impediments for states to pass single-payer bills by waiving federal exemptions that apply to employer-sponsored health plans. The amendment passed on a bi-partisan vote of 25-19, with the support of both progressive, si...

New Poll Shows Americans Continuing to Move Toward Pro-Life Position on Abortion

...it at all. 53% of Americans believe abortion does more harm than good to a woman in the long term. 79% of Americans support conscience exemptions on abortion for health care workers. This includes 64% of those who identify as strongly pro-choice. 69% of Americans think that it is appropr...

Health Insurance Options for Domestic Partnerships

...ax implications. Typically, health benefits provided to domestic partners through employers aren't exempt from federal tax liability, and state tax exemptions vary. The benefits could be recognized as income, and pre-tax dollars from flexible spending accounts or health savings accounts cannot be used to cov...

AMDL Inc. Announces Second Closing of Private Placement of Series 2 Senior Notes

...933, as amended (the "Securities Act"), and may not be offered or sold in the United States unless registered under the Securities Act upon applicable exemptions from registration under the Securities Act. About AMDL: Headquartered in Tustin, CA with operations in Shenzhen, Jiangxi, and Jilin, China,...

China Medicine Announces First Quarter 2009 Results

...me period a year ago. The increase was subject to an effective income tax rate in China of 25% in 2009, versus a reduced rate of 16.5% in 2008, as tax exemptions enjoyed by the Company's Konzern subsidiary ended in 2008. Net income for the first quarter of 2009 was $0.55 million, or $0.04 per diluted sha...

OnCore(r) 9.0 Released: 'Top 5' Priorities and Collaborative Initiatives Cornerstones of Product Development

... staff activities, the addition of user-defined annotations, the ability to track additional Investigational New Drug (IND) and Investigational Device exemptions (IDE) information, and new data export capabilities. "Special mention must be made of all the centers who collaborated with us on this versi...

Report Ignores True Value of Chicago Hospitals

...s provide nearly five times the value of their tax exemptions NAPERVILLE, Ill. and CHICAGO, April 10 /PRNew...premise of the report - comparing the value of tax exemptions and charity care and concluding that the hospitals...Accountability, "An Update: An Analysis of the Tax exemptions Granted to Non-Profit Hospitals in Chicago and the...

Harvest Technologies Announces Interim Study Results From Critical Limb Ischemia Trial in Chennai India

...d to be approved by all regulatory bodies in India," and was conducted in accordance with the significant risk provision of the Investigational Device exemptions Regulations (21 CFR Part 812); the Protection of Human Subjects Regulations, including Subpart B Informed Consent of Human Subjects (21 CFR Part50); t...

Exemptions in Medical Technology

AMT Receives EMEA Orphan Drug Designation for Acute Intermittent Porphyria

...r the European Union. The designation also provides for special benefits, including research support, eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval. "We are proud to have receive...

Micromet Expands Committed Equity Financing Facility to $75 Million

...may not be offered or sold in the United States absent registration under the Securities Act of 1933 and applicable state securities laws or available exemptions from registration requirements. Micromet has agreed to file a registration statement for the resale of the shares of common stock issuable in connecti...

Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenous Leukemia

... disease or condition generally characterized by a small number of patients. These incentives include eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees during development or at the time of application for marketing approval. Once approved, the product may quali...

Anthera's A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease

...the sponsor of the product is offered incentives which include eligibility for research grants, certain tax benefits, protocol assistance and possible exemptions or reductions of certain regulatory fees during development or at a time of market approval. About Anthera Pharmaceuticals Anthera Pharmaceuticals...

Celldex Therapeutics Announces Orphan Drug Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma Multiforme

...the sponsor of the product is offered incentives which include eligibility for research grants, certain tax benefits, protocol assistance and possible exemptions or reductions of certain regulatory fees during development or at a time of market approval. About Celldex Therapeutics, Inc. Celldex Therapeutics...

Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System

...etermined that the Company's clinical study is a non- significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. For more in...

Imaging Diagnostic Systems CTLM Technology Presented at Congress of World Society for Breast Health

...determined that the Company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. The CTLM syst...

Exemptions in Biological News

CABI helps phase out dangerous pesticide in EU

...t control. As a result they sought exemption for so-called critical use of methyl bromide from the protocol. In order to help reduce the number of exemptions being awarded in the EU, CABI and its partners worked with the European Commission to develop and implement a system to assess requests for the critic...

Exemptions in Biological Technology

MannKind Agrees with Pfizer on the Purchase of Frankfurt Insulin Manufacturing Plant

...ot be offered or sold in the United States absent registration under the U.S. Securities Act of 1933 and applicable state securities laws or available exemptions from registration requirements. If MannKind issues such shares, MannKind has agreed to file a registration statement with respect to the resale of suc...

Imaging Diagnostic Systems Exhibits at Major Middle East Health Conference

...determined that the Company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. For more...

Governor Rendell Says Life Science Industry Will Fuel New Breakthroughs, Generate Jobs for Decades to Come

...mount of state research and development funding and venture capital investments, the level of concentrated occupational employment in biotech; and tax exemptions and university grant funding. "We need to do even more to spur medical innovation in order to deliver solutions to our national health care c...

Imaging Diagnostic Systems CT Laser Mammography (CTLM) Technology Featured in Peer-Reviewed Journal

...determined that the Company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. The C...

Imaging Diagnostic Systems CT Laser Mammography (CTLM(R)) System Featured at the 94th Annual Radiological Society of North America (RSNA) Conference

...determined that the Company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. For m...

Imaging Diagnostic Systems is Recognized for Its Advanced Engineering in Time-Resolved Techniques by the US Patent Office

...determined that the Company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. The CTLM sys...

Imaging Diagnostic Systems Sells Its CT Laser Mammography System to Budapest, Hungary

...determined that the Company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. The CTLM syst...

Imaging Diagnostic Systems Receives its First Order for its CT Laser Mammography System for Israel

...determined that the Company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. The CTLM syst...

Pennsylvania Governor Rendell Says State Number 1 in New Biotechnology Study

...criteria, including the amount of state R&D funding and venture capital investments; the level of concentrated occupational employment in biotech; tax exemptions and university grant funding among other factors. "Biotechnology plays a critical role in Pennsylvania's economic and strategic growth," Governor Re...

Medical Ventures Becomes Neovasc with Two Corporate Acquisitions and $8.3 Million Financing

...een or are expected to be registered under the United States Securities Act of 1933 and may not be offered or sold in United States except pursuant to exemptions from or registration under that Act. Neovasc expects to file a registration statement under the Securities Exchange Act of 1934 in the immediate futur...