No abstract

The US Food and Drug Administration's (FDA's) generic drug program has dramatically increased the availability of affordable, high quality generic drugs. The foundation of generic drug approvals is a two-tiered regulatory framework of pharmaceutical equivalence and bioequivalence. Intrinsic to both of these is consideration of the clinical relevance of formulation and bioequivalence data to support an inference of therapeutic equivalence, based on clear evidence that there are no significant differences between the generic drug and the brand name drug. These analyses allow FDA to determine that the generic drug will perform in the patient in the same way, with the same safety and efficacy profiles, as the brand name drug. Allowable differences and the precise definition of what is meant by equivalence are critical to maintaining the quality, efficacy, and safety of generic drugs. The FDA Office of Generic Drugs' (OGD's) Clinical Safety Surveillance Staff (CSSS) has developed investigative processes that complement the broader FDA safety efforts that focus on the potential impact of allowable differences and equivalence determinations for generic drugs. Two recent examples of the CSSS's processes include a clonidine transdermal system and lansoprazole oral disintegrating tablet. Ongoing efforts of the CSSS result in improvements to the FDA's review processes and the quality of generic drugs in the US market.

The current literature suggests that more than 95% of males with cystic fibrosis (CF) are infertile, in contrast to approximately 50% of their female counterparts who may conceive. The present study examines patterns of fertility in a group of patients with CF based on clinical and laboratory studies performed over a longitudinal period of several years at the Georgetown University Cystic Fibrosis Clinic. Among the eight cases presented, four were female and four were male. Three women delivered three babies; two each delivered a live baby, a third a stillborn, and the fourth remained childless. Among the four men, one pro¬ created one son, another patient two sons, and an additional two patients remain childless.