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When assessing the risks of an investigational drug, drugmakers may need to build larger safety databases, especially in connection with proposed treatments for which a safe and effective alternative is already in use, according to an FDA draft guidance on risk management released yesterday.
Following up on risk management concept papers issued last spring, the FDA yesterday released three draft guidances to help drug manufacturers achieve more benefits from drug and biologic products while minimizing their risks.
Major changes in the drug industry combined with increased demand for new drug therapies has prompted the FDA to issue a revised guidance to help the pharmaceutical industry determine how they should report postapproval manufacturing changes for new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
Acting FDA Commissioner Lester Crawford announced late last month that the agency won’t release its multicenter analysis of cGMPs until August, roughly two months later than previously planned.
The FDA has ordered all manufacturers of exocrine pancreatic insufficiency drug products (PIDs) to submit new drug applications (NDAs) to the agency and have them approved within the next four years if they expect to remain on the market.
The biotechnology industry is looking for a great deal more FDA guidance on how to navigate the drug approval process for biological products, according to an industry attorney.
In August, the FDA will release a long-awaited multicenter analysis of current good manufacturing practices (cGMPs), according to acting FDA Commissioner Lester Crawford.
The FDA has set its regulatory sights firmly on the dietary supplement industry, saying it will more closely monitor the products and vigorously pursue enforcement actions against those it considers unsafe, just one week after issuing its final rule banning supplements containing ephedra took effect.
GlaxoSmithKline (GSK) Canada has begun to restrict shipments of prescription medicines to certain internet pharmacies in Canada known to export drugs to the U.S. and elsewhere.
Approving a generic biologic would require the FDA to rely on an innovator firm’s trade secret data covering the product’s manufacturing process — something that is prohibited by law, argues biotech firm Genentech.