The Food and Drug Administration (FDA) has issued notice of the availability of a guidance entitled "Q8 Pharmaceutical Development." The guidance describes the suggested contents for the pharmaceutical development section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format and indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. Written or electronic comments on agency guidance may be submitted at any time. (D/N 2005D-0021, FR Pub 05/22/06 available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-7727.pdf)
EchoStar and DirecTV’s 5-year agreement to sell WildBlue’s satellite-based Internet access service in rural markets provides a jump start for a technology that has struggled for years to attract an audience. While research firms have put the potential market for satellite broadband services in rural areas at 10-15 million households, HughesNet (formerly Direcway), StarBand and WildBlue have gained less than 500,000 combined, industry officials said.
EchoStar and DirecTV’s 5-year agreement to sell WildBlue’s satellite-based Internet access service in rural markets provides a jump start for a technology that has struggled for years to attract an audience. While research firms have put the potential market for satellite broadband services in rural areas at 10-15 million households, HughesNet (formerly Direcway), Starband and WildBlue have gained less than 500,000 combined, industry officials said.
The House Appropriations Committee Tues. restored $20 million of $115 million in public broadcasting funding cut last week by the Labor-HSS Subcommittee. While restoring CPB 2007 funding levels to $400 million, it didn’t provide advance CPB appropriation for FY 2009, or FY 2007 funding for public TV and radio digital conversion. It also eliminated funding for Ready to Learn. CPB Pres. Pat Harrison said public broadcasters’ funding request marks “both a strong commitment to fiscal restraint and a firm understanding of the value and service that public broadcasting offers.” Public broadcasters understand the “difficult choices” House appropriators face, but they are “nonetheless committed to funding levels in our original request,” she said. “It’s a shame that a majority of the House Appropriations Committee has decided to put Congress through another fight over funding for public broadcasting,” said APTS Pres. John Lawson. Many members decry indecency on TV but voted to kill funding for noncommercial educational kids’ programming, he said: “They call for improving education and teacher quality, but zero out funding that uses technology to bring professional development to teachers.” The appropriators voted against funding public TV’s satellite interconnection system while colleagues introduced a bill that would make it the backbone of a new national emergency alert system, he said. They also cut funds for digital broadcasting when Congress mandated an end to analog broadcasting, he said: “This action seems to be [in] willful disregard [of] what public broadcasting means to America.”
Net neutrality crusaders licked their wounds Fri. and promised to fight hard in the Senate. The House rejected 152-269 a measure sponsored by House Telecom Subcommittee Ranking Member Markey (D-Mass.) and backed by an amalgam of Internet firms, consumer and public interest advocates and religious and family groups (CD June 9 Special Report). While the movement has its supporters in the Senate, like Sens. Snowe (R-Me.) and Dorgan (D-N.D.), Internet players said it’s too soon to tell how they'll fare on the other side of Capitol Hill. Meanwhile, telco and cable hailed their House victory.
Net neutrality crusaders licked their wounds Fri. and promised to fight hard in the Senate. The House rejected 152-269 a measure sponsored by House Telecom Subcommittee Ranking Member Markey (D-Mass.) and backed by an amalgam of Internet firms, consumer and public interest advocates and a few religious and family groups (WID June 8 Special Report). While the movement has its supporters in the Senate, like Sens. Snowe (R-Me.) and Dorgan (D-N.D.), Internet players said it’s too soon to tell how they'll fare on the other side of Capitol Hill. Meanwhile, telco and cable hailed their House victory.
Saying encrypted data increasingly hamper police work, the U.K. Home Office Thurs. proposed requiring individuals to put protected electronic data in intelligible form or provide a key with which to make it so. The draft code of practice - - a guidance to police bodies seeking to force disclosure of encrypted data -- appears in the Regulation of Investigatory Powers Act (RIPA), most of which was adopted in 2000. The code hasn’t been put in place due to slower than anticipated deployment of encryption and other data protection technologies, the govt. said. But the past 2-3 years, personnel probing terrorism and crime have run into the technologies more often, the govt. said. Comments are due Aug. 30 -- encryption@homeoffice.gsi.gov.uk. The Home Office also seeks comments on a draft code of practice -- also required under RIPA -- governing acquisition and disclosure of communications traffic data, but not content. The govt. uses the data in criminal and civil matters, but can only collect them for: (1) National security. (2) Detecting or preventing crime. (3) Guarding the U.K.’s economic well- being. (4) Protecting public safety. (5) Guarding public health. (6) Assessing or collecting taxes or levies. (7) Preventing injury or death in an emergency. If adopted, the code will let police and emergency services, revenue and customs agencies and local authorities and other entities access traffic data under certain conditions. Comments due Aug. 30 -- commsdata@homeoffice.gsi.gov.uk. Protected data are of particular concern when suspects in grave cases must be set free because data can’t be read in time, Simon Watkin of the Home Office covert investigation policy team said. A draft of the code of practice appeared in 2000 parliamentary debates of RIPA, but the Thurs. version, differs greatly and handles issues raised then, Watkin told us. But the govt. is still “faced with the situation that we are writing a code of practice for a process which doesn’t exist,” he said.
Public broadcasters braced for a new Capitol Hill funding fight as the House Labor-Hill Appropriations Committee Wed. voted to cut $115 million in federal funds. “It’s familiar but distressing territory,” NPR Vp-Govt. Relations Mike Riksen said. The cuts would especially hurt public radio because stations are in the midst of transitioning to digital, he said. Last year it took a massive grass-roots campaign that included stations using on- air appeals to get the House to reverse more than $100 million in funding cuts.
Fixed Satellite Services (FSS) firms with operations over the U.S. are preparing for a busy hurricane season by setting aside satellite capacity and pre-positioning as much ground gear as possible, they said. The 2005 storm season brought significant Ku-band capacity demand and a rush for mobile, easy-to-use satellite communications gear, said executives we spoke with at Intelsat, Loral, PanAmSat and SES Americom. Major U.S. satellite operators are working to make sure enough Ku-band and gear are available -- and more quickly -- this year, they said.
ORLANDO -- The front projector market is a tale of 2 extremities, one segment careening toward ever-lower prices, the other bracing for the arrival of the first DLP-based models with 1080p native resolution. Both sectors were in evidence Wed. as the Infocomm show opened here, with Epson unveiling the S4 Powerlite front projector with 800x600 resolution and a $699 suggested retail price. A host of other vendors showed units at $15,000-$20,000, most bearing Texas Instruments’ 0.95” DLP chip with 1920x1080p resolution.