Newsletter - November 12, 2015
GMP Compliance at Indian Drug Manufacturers Questioned by RAPS
Two weeks ago, I wondered if Indian GMP manufacturers are indeed as bad as one would be led to believe based on the constant headline news of FDA’s audit notices to manufacturing sites in India. A review of FDA’s inspections database shows that the truth may be somewhere in the middle. Indian GMP sites are found to have issues but more often these issues are minor and get addressed voluntarily by the manufacturers when pointed out. Read More..
FDA Regulation of E-Cigarettes Creates New Opportunities
Since the passing of Tobacco Control Act in 2009, FDA has been actively and aggressively going after all tobacco products. Last week we discussed in details the actions FDA has taken to strictly regulate sale of tobacco products, primarily cigarettes. One thorn on FDA’s side has been e-cigarettes which currently FDA cannot regulate. In the 2009, FDA tried to seize e-cigarette products calling them “unregulated drug delivery” devices, but had to step back after courts refused to allow FDA jurisdiction over e-cigarettes. Read More..
GMP Compliance at Indian Drug Manufacturers Questioned by RAPS
Two weeks ago, I wondered if Indian GMP manufacturers are indeed as bad as one would be led to believe based on the constant headline news of FDA’s audit notices to manufacturing sites in India. A review of FDA’s inspections database shows that the truth may be somewhere in the middle. Indian GMP sites are found to have issues but more often these issues are minor and get addressed voluntarily by the manufacturers when pointed out. Read More..
FDA Regulation of E-Cigarettes Creates New Opportunities
Since the passing of Tobacco Control Act in 2009, FDA has been actively and aggressively going after all tobacco products. Last week we discussed in details the actions FDA has taken to strictly regulate sale of tobacco products, primarily cigarettes. One thorn on FDA’s side has been e-cigarettes which currently FDA cannot regulate. In the 2009, FDA tried to seize e-cigarette products calling them “unregulated drug delivery” devices, but had to step back after courts refused to allow FDA jurisdiction over e-cigarettes. Read More..
