References in periodicals archive ?
Shire Receives Health Canada Approval for VPRIV for Treating
Putnam Seabury secured all necessary approvals from the NYCDEP in 1999, and in fact, were the moving force behind the innovative demonstration Phosphorus Offset Program adopted by New York City.
The move to accept shorter trials comes as the consequences from the first round of rapid approvals are becoming painfully clear.
The company expects to file Abbreviated New Drug Applications ("ANDA") with the Food and Drug Administration in the United States and also seek approvals from European regulatory authorities for these products.
Drug firms would never advocate substantially loosening the FDA's bottleneck on approvals, the observer says, "because the current system lets [drug companies] earn near-monopoly profits.
The impact of the increasingly more conservative regulatory environment on accelerated approvals in oncology.
NYSE: BNT), a specialty pharmaceutical company, today announced its latest product launch and marketing approvals in the European Union (EU).
Once all approvals are secured RWE is expected to sell its shares of American Water through a public offering in the United States.
Beplate went on to add: "While these factors have contributed to unsatisfactory third quarter results, we believe that obtaining all of the necessary regulatory approvals is the only way that we will be able to freely market the NanoMask and NanoMask filters.
We are very pleased to now have eight FDA approvals this year and look forward to working with our partner on the launch of our generic version of 15 mg Ditropan XL," said Larry Hsu, President and Chief Executive Officer of IMPAX Laboratories.
These statements involve known and unknown risks and uncertainties that may cause the Company's actual results or outcomes to be materially different from those anticipated and discussed herein including, but not limited to, the successful completion of its pilot pharmacokinetic feasibility studies, the ability to develop products (independently and through collaborative arrangements), the ability to commercialize and obtain FDA and other regulatory approvals for products under development and the acceptance in the marketplace for lingual spray products.
The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K.
Myriad-Tunica has been granted development and gaming site approvals for the Tunica resort.
The Department of Water Resources (DWR) today announced it has all necessary environmental permits and regulatory approvals to repair 29 critical levee erosion sites.
This first MEA approval for on-site power generation will allow property owners, architects, and engineers to secure the necessary plan approvals from the Department of Buildings and the Fire Department so building permits can be issued for installation of Capstone Branded products," said Tucker.