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FDA Takes Regulatory Action Against 21 Websites Selling Unapproved Opioids

FDA announced in August that it had warned four online networks operating 21 websites that they were illegally marketing dangerous, misbranded and unapproved opioids. One of them was tramadol. The FDA warning letters to each network stated that they must cease selling the products to consumers. According to FDA Commissioner Scott Gottlieb, selling opioids online [...]

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FDA Plans to Revisit PMTA Process in 2018 and 2019

Approximately one year after it announced a tobacco strategy that features nicotine levels in regular cigarettes and other similar measures to cut tobacco use, FDA stated that it intended to take another look at the process it uses to evaluate new products containing tobacco, as well as how the agency approves them for sale and [...]

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FDA’a Regulatory Dilemma on e-Cigarettes

Many experts in the FDA regulatory industry say that FDA has a serious regulatory issue on its hands with e-cigarettes. In a sense, the US government may want to encourage people to use e-cigarettes; if e-cigs were to replace cigarettes entirely, it is certain that this would save lives and billions of dollars in medical [...]

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Sun Pharma Plant in India Hit with FDA 483

FDA inspectors in early September 2018 spotted several GMP issues at Sun Pharm’s manufacturing facility in Halol, Gujarat, India. This OAI inspection result put the drug manufacturing facility back in the spotlight after it got the green light from FDA in 2017. The pre-approval inspection noted six GMP related problems, including issues with the plant’s [...]

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FDA Makes Clarifications About Making Inspection Results More Visible to Public

In early September 2018, FDA published new information about how it chooses and schedules drug manufacturing plant inspections all over the world, and the process that it uses to release the findings of those actions. FDA states that the more international nature of the pharmaceutical supply chain is making the agency revise how it does [...]

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FDA Provides Update on Risk-Based Drug Inspections

FDA announced in early September 2018 that it had released CDER’s Manual of Policy and Procedures or MAPP, called Understanding CDER’s Risk Based Side Selection Model. FDA provided some clarification of how it is prioritizing routine pharmaceutical manufacturer inspections. However, it failed to give any information on how predictable FDA inspections will be, or did it [...]

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Regulatory Oversight in Drug Compounding on the Rise

Drug compounding until very recently has had a lot looser regulation than that of pharmaceutical drugs. The looser regulations served a real function: It allowed people who need a very specific drug formulation that was not available in a widely manufactured product. This could include discontinued drugs or specific forms of current drugs that do [...]

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Indian Company Pan Drugs Redoing API Program After FDA Warning Letter

Pan Drugs in India got an FDA warning letter this week, with the federal agency citing the company for several GMP problems. The facility is located in Nadesari, Vadodara. FDA stated that the company did not maintain, repair and keep its API manufacturing units clean. FDA noted that there were holes in the roof and [...]

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Canada Hits Dr. Reddy’s With Import Ban

Indian drug manufacturers are now coming under tough scrutiny of Canadian drug regulators. Health Canada this week stated that Canadian importers of drugs are  putting an import ban on drug products from Dr. Reddy’s Laboratories, as well as IPCA Laboratories. Health Canada stated that Canadian drug importers are quarantining health care products from these two [...]

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Impax Hit With Another FDA 483

Impax Laboratories was hit with its second FDA 483  recently on its plant in Hayward CA. This follows an inspection and 483 for its plant in Taiwan earlier this year. This latest 483 came just a few months after Impax stated that it was confident that its manufacturing processes were good enough to resubmit an [...]

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