US and EU Regulations Update

December 23, 2005 | Contact Author | By: David C. Steinberg, Steinberg & Associates
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Keywords: regulations | United States | EU

Abstract: United States – OTC Drug Review Call for Data On December 31, 2003, the FDA announced a call for data for an OTC drug review, for drugs that have not been reviewed as of this date. These include drugs sold before 5/11/72 (when the OTC drug review began) and identified by OTC category. Also included are OTC drugs marketed before 12/4/75 and described the DA’s general regulatory policy. The call for data covers these categories of ingredients, some of which have been considered to be cosmetics, not drugs: nasal moisturizer drug products, urinary analgesic/antiseptic drug products, urinary acidifiers and alkalinizers, aloe vera and urea, wrinkle remover products, lubricants and vaginal moisturizers.

United States – OTC Drug Review Call for Data On December 31, 2003, the FDA announced a call for data for an OTC drug review, for drugs that have not been reviewed as of this date. These include drugs sold before 5/11/72 (when the OTC drug review began) and identified by OTC category. Also included are OTC drugs marketed before 12/4/75 and described the DA’s general regulatory policy. The call for data covers these categories of ingredients, some of which have been considered to be cosmetics, not drugs:

  1. Nasal moisturizer drug products
  2. Urinary analgesic/antiseptic drug products
  3. Urinary acidifiers and alkalinizers
  4. Aloe vera and urea
  5. Wrinkle remover products
  6. Lubricants and vaginal moisturizers