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Home » Topics » Publication » Executive Briefing Series (formerly The Food & Drug Letter)
Executive Briefing Series (formerly The Food & Drug Letter)
Regenerative medicine is a rapidly expanding, lucrative field and continued growth is expected. Sections 351 and 361 of the Public Health Service Act (PHS Act) [42 USC 264] aim to prevent the introduction, transmission and spread of communicable diseases through the procurement, processing and use of certain human cells, tissues, and cellular and tissue-based products (HCT/Ps) in regenerative medicine. Section 351 is the more stringent of the two because HCT/Ps that fall under that section are regulated as drugs, devices and biological products. The FDA implemented 21 CFR Part 1271 — Human Cells, Tissues, and Cellular and Tissue-based Products to define and regulate HTC/Ps in conjunction with Sections 351 and 361 of the PHS Act. Read More
Environmental and biological monitoring of drug manufacturing sites gives drugmakers the information they need to comply with FDA and EU regulations on the manufacture of sterile drug products. Monitoring provides critical information on the hygienic status of the sites and thus on the success of cleaning and disinfecting measures. Surfaces, personnel, air, utilities and cleansing agents and disinfectants all have to be tested. Alert and action limits have to be set, as well as measures to be taken if those limits are exceeded. Read More
Each step in the drug manufacturing process involves potential risks to the product quality and,
as a result, to the patient. However, the risks associated with manufacturing are only one part of the overall risk to the drug during its life cycle. This life cycle includes the development of drug substances, the manufacture of drug substances and excipients, the development of the drug, clinical testing, manufacture, marketing and use by patients, and ends with its withdrawal from the market. Read More
The steady growth over the past decade in abbreviated new drug applications (ANDAs) from both domestic and foreign generic drug manufacturers has led to a backlog of applications at the FDA. It now takes the agency on average about three years to review and approve a typi-cal ANDA. Read More
In 2014 European regulators began inspecting drugmakers for compliance with new postmarket
reporting and surveillance requirements for drugmakers. They also have raised the bar
for winning a drug approval at the European Medicines Agency, which now requires drugmakers
to design and implement a substantial safety plan for each drug. While drugs have always
had to meet safety regulations, the new rules demand much stronger and thoroughly prepared
pharmacovigilance activities on the part of drugmakers. Read More
Manufacturers must conduct labeling self-audits not only to ensure that their product label-ing and package inserts meet quality assurance program and good manufacturing practice re-quirements, but also to ensure that labeling is consistent and up-to-date throughout the company and adheres to regulations in the U.S. and abroad. Read More
FDA oversight of pharmaceutical and device manufacturer promotional activities has taken on a new focus recently. While print and broadcast ads have previously been the primary targets of agency scrutiny, the FDA now is also examining manufacturers’ postings on websites and social media, such as Facebook and Twitter, along with presentations at medical meetings and promotional materials in booths at industry trade shows. Read More