FDA Articles

When an FDA inspection is imminent, it pays to have a plan. Start by getting your papers in order and your facility in a state of good repair. Train a team to manage interaction with inspectors. Coach your employees o­n how to answer questions. And don't forget to take notes.

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Digoxin elixirs could vanish o­n June 28. That's the deadline set by the Food & Drug Administration back in 2002. The agency ruled that digoxin makers must obtain formal drug approvals under New Drug Application or Abbreviated New Drug Application procedures for oral formulations. Digoxin tablets had 30 days to meet new approval requirements. Elixirs got two years. At deadline, none of the four elixir suppliers listed in the National Drug Code Directory—Cardinal Health, GlaxoSmithKline, MedPro, and Roxane Laboratories—had received FDA marketing approval yet. An FDA spokeswoman declined to comment o­n the deadline or o­n the agency's plans to enforce the deadline or allow an extension. "Pharmacy and medicine need absolute guidance o­n this issue," Susan Winckler, VP of policy and advocacy for the American Pharmacists Association, told Drug Topics.

New proposals encourage computerized systems and aim to simplify post-approval changes and avoid problems with sterile products.

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Pharmaceutical & Medical Packaging News
July 2000

Michael Conlon
Drug Topics, Jan 1, 2001

New technologies, along with changes in FDA oversight, may provide a critical path to make more new drugs available more quickly to patients.


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Synthroid (levothyroxine sodium, Abbott), a 42-year-old treatment for hypothyroidism, must now be proven to be safe and effective in order to stay o­n pharmacy shelves. The Food & Drug Administration recently rejected a citizen petition from Knoll Pharmaceutical filed in 1997. The petition sought continued marketing approval for Synthroid without submitting clinical studies. Abbott last March acquired Knoll, which had bought Synthroid from Boots in 1995.

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FDA's latest proposal focuses o­n electronic health systems for filing drug labeling information and facility and product data.


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Spooked by the quantum leap in drug counterfeiting cases in the United States in the past two years, the Food & Drug Administration is taking steps to keep the nation's drug supply in as pristine a state as possible. Speaking at the National Association of Chain Drug Stores' pharmacy and technology conference in Philadelphia last month, Thomas McGinnis, R.Ph., FDA's deputy associate commissioner, said that a task force the agency has formed would issue an interim report with draft recommendations this month. Then a public conference would be held next month in Washington, D.C., to get feedback from manufacturers, wholesalers, pharmacists, and technology vendors. This would culminate with a final report to be released next January.

FDA labeling regulations protect consumers and ensure product identity.

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