Outsourcing safety

March 2009
Nature Medicine;Mar2009, Vol. 15 Issue 3, p221
Academic Journal
The author reflects on global outsourcing of domestic drug manufacturing in the U.S. He contends that the trend of outsource drug manufacturing raises the issue on whether sufficient mechanisms are in place to ensure safety of imported pharmaceuticals. He suggests that the process of effective oversight must be restored and ramifications for drug importers be established. Efforts of the Food and Drug Administration (FDA) to regulate safety of food, drugs and medical products are tackled.


Related Articles

  • Medications without borders.  // Pharmacy Today;Aug2010, Vol. 16 Issue 8, p44 

    The article focuses on the challenges of the Food and Drug Administration (FDA) on supply chains complexity of pharmaceutical market due to imported products in the U.S. It cites the laws, culture, economic, and language challenges of the FDA in keeping the safety of Americans on adulterated...

  • Risks and Benefits of Importing Prescription Medications From Lower-Income Countries. Dhalla, Irfan A.; Detsky, Allan S. // JAMA: Journal of the American Medical Association;9/24/2008, Vol. 300 Issue 12, p1453 

    The article discusses the import of prescription medicine into the U.S. from lower-income countries, comparing the benefits and risks of such a policy to the American consumer. India's rapidly increasing share in the global pharmaceutical market is noted by the authors. Topics include the rapid...

  • Ipca Shares Slip 4 Per Cent On FDA Warning Letter.  // Business World;2/2/2016, p1 

    The article reports that the drugmaker Ipca Laboratories has slipped in the shares after it received warning letters from the U.S. Food and Drug Administration (FDA) on compliance issues with export facilities. Topics discussed include suspending exports of active pharmaceutical ingredients...

  • Accidents with fentanyl patches a serious concern. Tanzi, Maria G. // Pharmacy Today;Sep2012, Vol. 18 Issue 9, p60 

    The article reports on the safety alert released by the U.S. Food and Drug Administration (FDA) reminding caregivers, clinicians and patients about the potential for serious adverse events resulting from accidental exposure to fentanyl transdermal patches. The FDA warned that pediatric patients...

  • Proper disposal of fentanyl patches can save lives.  // Pharmacy Today;Sep2012, Vol. 18 Issue 9, p80 

    The article reports on the safety alert released by the U.S. Food and Drug Administration (FDA) reminding caregivers and patients about the importance of proper storage, application and disposal of transdermal fentanyl patches to prevent accidental exposure. The FDA cited 26 cases of accidental...

  • Daytrana patch causes loss of skin colour.  // Reactions Weekly;Jul2015, Vol. 1559 Issue 1, p1 

    An abstract of the article "FDA Drug Safety Communication: FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal system) for treating ADHD" is presented.

  • FDA tightens control over India’s API manufacturers. RAMESH, DEEPTI // Chemical Week;6/23/2014, Vol. 176 Issue 17, p31 

    The article examines regulation by the U.S. Food & Drug Administration (FDA) of active pharmaceutical ingredient (API) manufacturing plants located in India. Warning letters sent by the FDA to pharmaceutical industry firms including Apotex, Canton Laboratories and Fresenius following inspections...

  • Prescription ads next on FDA list. Colford, S.W. // Advertising Age;8/26/91, Vol. 62 Issue 35, p32 

    Examines Food & Drug Administration (FDA) plans to tighten regulations on drug advertising and various promotional practices. Principal concerns of Commissioner David Kessler; Present regulations of consumer ads for prescription drugs.

  • Over-the-counter drugs. Sommi Jr., R.W. // Current Health 2;May92, Vol. 18 Issue 9, p21 

    Discusses the differences between prescription and nonprescription drugs (also called over-the-counter, or OTC, drugs). Role of the US Food and Drug Administration (FDA); OTC drugs for self-limiting illnesses such as the common cold; The FDA's concern about side effects, clear instructions and...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics