Bangalore Blast Images Madiwala

July 25, 2008

Blasts in Bangalore

July 25, 2008

One woman has been reportedly killed and about 15 injured in six blasts that rocked the southern city of Bangalore today (July 25), police officials said. Confirming the reports of blasts, Police Commissionser of Bangalore — Shankar Bidri — said that expolsives were hidden in relatively crowded areas of the city. The first blast took place at around 1:30 pm at the Madivala checkpost in the city. The other blasts have been reported from Adugudi, Ashoknagar, Hosur, Koramangala and Langford town.

Docs like hearing from reps, survey says

July 25, 2008

Pharma reps have been getting a tough shake lately, what with massive layoffs and a new industry code that curtails some tried-and-true sales techniques. Not to mention efforts to ban them altogether from various academic institutions and even require licensing in the District of Columbia. Now, though, a new study offers a welcome respite: More than three-fourths of doctors say they’re willing to see reps any time of day, and only one-fourth require an appointment.

17 percent of the 230,000 medical practices surveyed said they don’t admit reps at all. Some 30 percent of hospital-owned practices bar reps, and another 40 percent require appointments. But still, that leaves 83 percent of docs open to sales-rep input.

See the doc survey at Pharmalot

FDA to outsource manufacturing inspections

July 25, 2008

The US Food and Drug Administration (FDA) is pushing for Congress to approve the use of more third-party inspectors as the regulatory body attempts to police a complex global supply chain.

By outsourcing some of the inspections the FDA believes that it can more efficiently use the $275m extra funding which it is hoping to receive.

The Government Accountability Office (GAO) has stated that foreign plants are inspected every 13 years as opposed to 2.7 years for facilities in the US, a situation the FDA is hoping to resolve.

However, the outsourcing plan has already drawn criticism, primarily targeted at the perceived failure of a similar scheme for inspections of device manufacturers.

The outsourcing idea was mooted last autumn, when the Bush administration proposed a plan for non-FDA inspections of prescription pharmaceuticals. This would be done on a voluntary basis for products that are not considered to pose too great a risk, with manufacturers paying for the inspections.

FDA relaxes GMP rules for Ph I candidates

July 25, 2008

The US Food and Drug Administration (FDA) has relaxed the regulatory good manufacturing practice (GMP) rules for drugs in early-stage clinical trials in recognition of the different requirements of trial scale and industrial scale manufacture.

The FDA‘s new regulatory guidance, which was detailed in a recent edition of the US Federal Register, removes the requirement that candidate drugs are produced using a fully validated manufacturing process.

The ruling, which comes into effect on September 15 and will apply to most candidate biologics, small molecules and vaccines, also removes some of the stock rotation requirements and labelling regulations that are applied to drugs produced on a commercial scale.

Drugmakers must still comply with statutory current good manufacturing practice (cGMP) guidelines and submit detailed information about their production processes as part of the investigational new drug (IND) application.

The new guidance liberates companies of some of the rules that are only really relevant to commercial scale production.

The move could encourage innovation in the drug discovery sector as it considerably lowers the cost of moving candidates from the laboratory to the clinic.

An agency spokesman explained that the: FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture.”