Government Shutdown Affecting FDA Drug Approvals
With the federal government shutdown in its second week, FDA is seeing delays in the approvals of new drugs. The FDA shutdown is starting to delay PDUFA dates for firms that are looking to get near term FDA approval. FDA panel reviews for new drugs that are under regulatory review also are getting delayed. Markets […]
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FDA Acting at Lower Capacity During Shutdown, But User Fees Helping
FDA as of Oct. 1 is operating at about 1/2 its normal capacity, due to Congress not passing a bill to appropriate funds to operate the US government, according to FDA. At the RAPS regulatory conference in Boston last week, the effects of the current shut down were evident. Even with hotel rooms already booked, […]
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FDA Favoring DUNS for Manufacturing Plant IDs in FDASIA
FDA stated early this month that the DUNS system is what it prefers for the identification of drug facilities, according to new draft guidance by the agency. This decision is coming after the signing of FDASIA, or the Food and Drug Administration Safety and Innovation Act. The new law has had a major effect on […]
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Surprise FDA Visits Rising in India
The next time an Indian drugmaker hears a knock at the door, it could be an FDA auditor coming to do a cGMP inspection. FDA has let it be known that it is following the exact same system of cGMP inspections that is being followed in the United States. This can include aggressive surveillance as […]
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Should Pharma Company Pay Punitive Damages?
Should a pharmaceutical company not have to pay out punitive damages for product liability, because the penalty will limit the ability of FDA to enforce its statutory authority? This is something that Novartis hopes that the Supreme Court is going to answer soon. It is not clear if the justices are going to agree to […]
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J&J Must Warn Consumers About Ties Between Talcum Powder and Ovarian Cancer
Source: Pharmalot A South Dakota federal jury last week decided that pharmaceutical giant Johnson & Johnson needs to warn consumers of a link between ovarian cancer and using J&J’s talcum powder, specifically for feminine hygiene. In coming to this decision, the jury decided that the product, called Shower to Shower, was a contributing factor for […]
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Pharmaceutical Shortages Persisting as Manufacturing Problems Continue
Some new drug shortages have been prevented with new early notification procedures, but many drug shortages are still going on because of cGMP manufacturing problems, according to some of our hospital sources. A new program that was put together by the generic drug makers in the US to stop shortages is not working because there […]
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Burzynksi Research Institute IRB Fails Yet Another FDA Audit
Source: Pharmalot It has happened three times since 2010 where an IRB has been found to violate several GCP procedures for clinical trials. The latest audit of the Burzynski Research Institute , based in Houston, found that there was a failure to ensure that safeguards were in place for children, and a lack of reporting […]
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With FDASIA, FDA Increases Inspections of Indian Drug Facilities
FDA has boosted the cGMP inspections of drug firms in India, which is the second biggest manufacturer of finished dose forms to the United States, which will help to increase compliance of approved cGMP regulations. FDA, which has cracked down on many pharma companies in India, which includes Wockhardt and Ranbaxy Labs, also is recruiting […]
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Indian Drugmaker USV Slammed With FDA 483
FDA is accusing Mumbai, India drugmaker USV of faking and fudging data, according to a 483 that stemmed from a June inspection of its laboratory. FDA stated in the 483 that the drug product testing for validation data is falsified. USV is one of the top drugmakers in India, and is the third manufacturer in […]
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