Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Usfda”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 55 records · Page 3Linked to original sources
PubMed2000

In vitro assessment of the structural integrity of the female condom after multiple wash, dry, and re-lubrication cycles.

Since the introduction of the female condom in the early 90s, there have been numerous reports of reuse of the device. In response to these reports, studies were undertaken to evaluate the safety of female condom reuse. If reuse were shown to be safe, then programmatic costs of introduction of the female condom would be reduced allowing it to be more widely available. This article outlines the results of in vitro structural integrity testing of the female condom after multiple wash, dry, and re-lubrication cycles. Devices were tested up to 10 washes using water leakage, burst, and tensile seam testing. All results were compared to the United States Food and Drug Administration (US FDA) standards for an unused female condom. The results of the structural integrity tests for all 6 washing procedures examined in this study were above the FDA minimum standards for seam strength and burst tests. For the water leakage test, 3 of 6 washing procedures tested passed the required FDA minimum standards (no holes detected). From the results of the study, it seems that washing, drying, and re-lubricating the female condom up to 10 times leads to some deterioration in the structural integrity of the device for specified washing procedures. Further studies are currently being conducted to establish the safety of female condom reuse with respect to microbial retention, structural integrity after in vivo use, and viral permeability.

Single-Use Internal Condom↗
PubMed1997

An in vitro evaluation of condoms as barriers to a small virus.

BACKGROUND: Because of the possible presence of small holes, the effectiveness of condoms as barriers to virus transmission is controversial. GOALS: To determine the proportion of condoms that allow virus penetration and the amounts of virus that penetrate. STUDY DESIGN: A sensitive, static test was used to evaluate different condom types as barriers to a small virus, including brand with or without lubrication and ones of different materials. The test included some physiologic-based parameters and some parameters that exaggerated expected actual use conditions. RESULTS: Under test conditions, 2.6% (12 of 470) of the latex condoms allowed some virus penetration; the median level of penetration was 7 x 10(-4) ml. Lubricated condoms performed similarly to nonlubricated ones. Polyurethane condoms yielded results higher than but not statistically different from those for latex condoms. CONCLUSIONS: Few condoms allowed any virus penetration. The median amount of penetration for latex condoms when extrapolated to expected actual use conditions was 1 x 10(-5) ml (volume of semen). Thus, even for the few condoms that do allow virus penetration, the typical level of exposure to semen would be several orders of magnitude lower than for no condom at all.

Bacteriophage phi X 174↗
PubMed1994

Labeling emergency contraception.

According to the signers of a November 28 citizens' petition filed with the Food and Drug Administration (FDA), unintended pregnancies and abortions could be reduced significantly if the FDA would require the relabeling of several oral contraceptives as emergency or postcoital contraception, also known as "morning after pills." It has long been established that within 72 hours after unprotected intercourse or contraceptive failure, a specified combination of pills taken at specified intervals can reduce the risk of pregnancy by an estimated 75%. Although physicians at university health clinics, in hospital emergency rooms treating rape victims, and at some family planning clinics prescribe emergency contraceptives, other physicians are reluctant to do so without relabeling, and most women taking the pill do not know the correct dosage. Calling this a "critical public health issue," attorneys at the Center for Reproductive Law and Policy petitioned the FDA for a labeling change on the grounds that manufacturers are in fact "misbranding" pills by suppressing emergency contraceptive information. If pill makers rewrite their patient packet inserts, women undoubtedly would have far greater control over the occurrence of an unintended pregnancy, the attorneys said.

Americas↗