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Drugs & Biologics

Sandler, Travis & Rosenberg brings experience in every phase of the regulation of prescription or over-the-counter pharmaceutical products by providing the following services.

  • Regulatory pathway counsel, including clinical trials and protocol development, regulatory and compliance issues relating to bulk and finished prescription and OTC drugs, approvals, advertising, marketing and distribution.
  • Submission and advisory services regarding the need to submit new drug applications and abbreviated new drug applications for generic drugs.
  • Compliance with published monographs for OTC drugs.
  • Counsel on good manufacturing practices, labeling and advertising matters, conducting product recalls, responding to warning letters and managing FDA inspections.
  • Compliance with requirements for the importation of pharmaceuticals from foreign manufacturers.
  • Registration of manufacturing facilities and application for National Drug Code NDC numbers.
  • Development of regulatory strategies for implementing novel business approaches.

Bioterrorism Act

In the aftermath of the events of Sept. 11, 2001, the U.S. government took a number of steps to better prepare the nation against all types of foreign attack. One of these measures was the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (commonly known as the Bioterrorism Act), which confers on the FDA specific functions with respect to protection of the food and drug supplies and was signed into law June 12, 2002. In 2004 Congress approved the Project Bioshield Act, which permits the FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces or a significant potential to affect national security.

ST&R helps clients who manufacture, distribute, import or export foods, drugs or medical devices meet all applicable requirements and be in compliance with the Bioterrorism Act. Our services include facility registration, food validation and certification, supply chain and border security programs, and seminars and webinars on regulatory requirements.

Gilbert Lee  Sandler
T: 305.894.1000
Founding Member
  • ST&R
Domenic J. Veneziano
T: 202-734-3939
Independent FDA Regulatory and Strategic Consultant
  • ST&R

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