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The Food and Drug Administration’s Pregnancy and Lactation Labeling Rule (2014)

In 2014, the United States Food and Drug Administration published the Pregnancy and Lactation Labeling Rule to amend previous guidelines for the prescription of drugs for pregnant and lactating women. The 2014 Pregnancy and Lactation Labeling Rule was intended to increase the safety and efficacy of prescription drugs by making drug labels easier for physicians to understand and utilize.

Format: Articles

Subject: Legal

“General Considerations for the Clinical Evaluation of Drugs” (1977), by the United States Food and Drug Administration

The United States Food and Drug Administration, or FDA, published 'General Considerations for the Clinical Evaluation of Drugs,' in September 1977. The document defined acceptable practices for investigators who studied new drugs. Specifically, the document outlined the common clinical trial methods. Clinical trials are studies to test whether a new drug is safe before doctors can prescribe it to patients. Prior to 1977, the Protection of Human Subjects Rule primarily regulated clinical drug trials, but it did not specify who could and could not be included in clinical trials.

Format: Articles

Subject: Publications

Physician Labeling Rule (2006)

In 2006, the United States Food and Drug Administration, or FDA, published the “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” also called the Physician Labeling Rule, to improve the safety and efficacy of prescription drugs and drug products. Within the Physician Labeling Rule, the FDA includes a section titled “Use in Specific Populations” or Section 8, which refers to drugs used by pregnant women, lactating women, and people of reproductive capacity.

Format: Articles

Subject: Legal

“Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs” (July 1993), by the United States Food and Drug Administration

The US Food and Drug Administration, or FDA, published the “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” henceforth “Study of Gender Differences,” in July 1993. The document defined acceptable practices for investigators studying new drugs. Prior to 1993, investigators excluded most women from clinical trials because in 1977, the FDA recommended that anyone who could possibly become pregnant be excluded from early phase drug research to minimize risk to a potential fetus.

Format: Articles

Subject: Publications

Retinoids As Teratogens

Vitamin A (retinol) is an essential vitamin in the daily functioning of human beings that helps regulate cellular differentiation of epithelial tissue. Studies have shown that an excess of vitamin A can affect embryonic development and result in teratogenesis, or the production of birth defects in a developing embryo. Excess intake of vitamin A and retinoids by pregnant women often results malformations to fetuses' skulls, faces, limbs, eyes, central nervous system.

Format: Articles

Subject: Disorders, Reproduction

US Regulatory Response to Thalidomide (1950-2000)

Thalidomide, a drug capable of causing fetal abnormalities (teratogen), has caused greater than ten thousand birth defects worldwide since its introduction to the market as a pharmaceutical agent. Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did. By 1962, approximately 20,000 patients in the US had taken thalidomide as part of an unregulated clinical trial before any actions were taken to stop thalidomide's distribution.

Format: Articles

Subject: Legal, Reproduction

The Development of Mifepristone for Use in Medication Abortions

In the 1980s, researchers at the pharmaceutical company Roussel-Uclaf in Paris, France, helped develop a biological compound called mifepristone. When a woman takes it, mifepristone interferes with the function of hormones involved in pregnancy and it can therefore be used to terminate pregnancies. In 2000, the US Food and Drug Administration approved mifepristone, also called RU 486, as part of a treatment to induce abortions using drugs instead of surgery, a method called medication abortion.

Format: Articles

Subject: Reproduction

“Improving Women’s Health”: Section 3509 of the Affordable Care Act of 2010

In 2010, US Congress enacted section 3509 of the Patient Protection and Affordable Care Act or ACA, to target issues relating to women’s health. The ACA, signed into law by US President Barack Obama, aimed to increase people’s access to high-quality healthcare in the United States.

Format: Articles

Subject: Legal

Plan B: Emergency Contraceptive Pill

Plan B is a progestin-only emergency contraceptive pill (ECP) that can be taken within seventy-two hours of unprotected sex in order to prevent an unwanted pregnancy. Plan B was created in response to the United States Food and Drug Administration's (US FDA) 1997 request for new drug applications (NDAs) for a dedicated ECP product, and was approved for sales in the US in 1999. Duramed, a subsidiary of Barr Pharmaceuticals, manufactures Plan B for The Women's Capital Corporation (WCC), which owns the patent for Plan B.

Format: Articles

Subject: Technologies, Reproduction

Zidovudine or azidothymidine

In 1964, Jerome Horwitz synthesized the drug zidovudine, commonly abbreviated ZDV, otherwise known as azidothymidine, or AZT, at Wayne State University School of Medicine in Detroit, Michigan. Horwitz and his colleagues originally developed zidovudine to treat cancers caused by retroviruses. In 1983, Nobel Prize in Physiology or Medicine recipients Françoise Barré-Sinoussi and Luc Montagnier discovered a new retrovirus, the human immunodeficiency virus, or HIV, at the Pasteur Institute in Paris, France.

Format: Articles

Subject: Processes

International Treaty on Plant Genetic Resources for Food and Agriculture (2001)

The International Treaty on Plant Genetic Resources for Food and Agriculture, referred to as the Plant Treaty, was approved on 3 November 2001 by Members of the Food and Agriculture Organization (FAO), headquartered in Rome, Italy. The FAO is an agency of the United Nations, headquartered in New York City, New York. The Plant Treaty established international standards for the conservation and exchange of plant genetic material between participating countries.

Subject: Legal

The Dalkon Shield

The Dalkon Shield was an intrauterine contraceptive device (IUD) that women used in the early 1970s and 1980s. Produced by the A.H. Robins Company in the US, the Dalkon Shield was a contraceptive device placed directly into a woman’s uterus that was supposed to prevent the development of a fetus in the uterus. In the 1980s, researchers uncovered an array of severe birth defects and injuries caused by the Dalkon shield, including pelvic infection, infertility, and death of the user. Eventually the A.H.

Format: Articles

Subject: Technologies

Diethylstilbestrol (DES) in the US

Diethylstilbestrol (DES) is an artificially created hormone first synthesized in the late 1930s. Doctors widely prescribed DES first to pregnant women to prevent miscarriages, and later as an emergency contraceptive pill and to treat breast cancer. However, in 1971, physicians showed a link between DES and vaginal cancer during puberty in the children of women who had taken DES while pregnant. Consequently, the US Food and Drug Administration (FDA) banned its use during pregnancy.

Format: Articles

Subject: Reproduction, Technologies

Leuprorelin as a Treatment for Endometriosis

Leuprolide acetate, or leuprorelin, is a manufactured drug that has been prescribed as a treatment for endometriosis, a medical condition in which body tissue that typically lines the uterus grows outside of the uterus, since 1989. Leuprorelin is a modified version of a gonadotropin-releasing hormone, a type of hormone that helps regulate the female menstrual cycle. The drug inhibits the production of estrogen, a female sex hormone that enables endometrial gland growth.

Format: Articles

Subject: Processes

NovaSure Endometrial Ablation

NovaSure is a device for endometrial ablation, which is a procedure that removes the endometrium, that the US Food and Drug Administration, or FDA, approved for use on 28 September 2001. Endometrium is the tissue that lines the uterus. NovaSure destroys the endometrium by sending electric beams at the endometrium. Hologic, a medical technology company concerned with women’s health, developed NovaSure to treat menorrhagia, or heavy bleeding during menstruation. Menorrhagia is a common symptom of endometriosis. Endometriosis is the growth of the endometrium outside of the uterus.

Format: Articles

Subject: Technologies

The Birth Control Pill

The birth control pill, more commonly known as "the pill" is a form of contraception taken daily in pill form and consisting of synthetic hormones formulated to prevent ovulation, fertilization, and implantation of a fertilized egg. The US Food and Drug Administration (FDA) approved the first birth control pill, Enovid, in June 1960. It was the first contraceptive pill marketed worldwide. Since then a number of different pills have been developed, which differ in hormone type and dosage, and whether they contain one hormone (the minipill) or two (the combination pill).

Format: Articles

Subject: Technologies, Reproduction

Cervarix HPV Vaccination Series

In 2011, United Kingdom pharmaceutical company GlaxoSmithKline released Cervarix, a vaccination series protecting girls and women from two strains of Human Papillomavirus, or HPV. HPV, a sexually transmitted infection, can present in men and women without symptoms, or may cause symptoms such as genital warts. There is a link between HPV and cervical, vaginal, anal, head, neck, and face cancers, and Cervarix can reduce genital cancers in girls and women, particularly cervical cancer.

Format: Articles

Subject: Technologies

Clomiphene Citrate

Clomiphene citrate, more commonly known by its brand names Clomid and Serophene, is a medication prescribed to women to stimulate ovulation in order to treat infertility. It stimulates ovulation in women who do not ovulate or ovulate irregularly. This drug was created by Dr. Frank Palopoli in 1956 while he worked for Merrell Company. It first successfully induced ovulation in women in 1961 and was approved by the Federal and Drug Administration (FDA) in 1967.

Format: Articles

Subject: Technologies

Title 1, Subtitle B, Parts I, II, and III of the “National Institutes of Health Revitalization Act of 1993” (1993)

In 1993, the NIH published the Revitalization Act that established guidelines for minorities’ and women’s participation in clinical research. Before the 1990s, investigators largely excluded women from their research based on the 1979 guidance from the US Food and Drug Administration, or FDA. The FDA urged investigators to exclude any woman who was or could become, pregnant to protect the woman and any developing fetuses from harm.

Format: Articles

Subject: Legal

Stem Cell Tourism

When James Thomson of the University of Wisconsin announced in 1998 that he had derived and cultured human embryonic stem cells(hESCs), Americans widely believed-and accepted-that stem cells would one day be the basis of a multitude of regenerative medical techniques. Researchers promised that they would soon be able to cure a variety of diseases and injuries such as cancer, diabetes, Parkinson's, spinal cord injuries, severe burns, and many others. But it wasn't until January 2009 that the Food and Drug Administration approved the first human clinical trials using hESCs.

Format: Articles

Subject: Theories, Ethics

“Improved Treatment for Cervical Cancer – Concurrent Chemotherapy and Radiotherapy” (1999), by Gillian Thomas

On 15 April 1999, physician Gillian Thomas published the editorial “Improved Treatment for Cervical Cancer – Concurrent Chemotherapy and Radiotherapy,” henceforth “Improved Treatment,” in The New England Journal of Medicine. In that editorial, she discusses the potential benefits of combining chemotherapy drugs with radiation to treat women with cervical cancer. At the time, healthcare professionals rarely treated cervical cancer by combining chemotherapy or radiation.

Format: Articles

Subject: Publications

Action of MER-25 and of Clomiphene on the Human Ovary (1963)

Between 1958 and 1962, physicians Olive W. Smith, George V. Smith, and Robert W. Kistner performed experiments that demonstrated the effects of the drugs MER-25 and clomiphene citrate on the female human body. MER-25 and clomiphene citrate are drugs that affect estrogen production in women. At the time of the experiment, researchers did not know which organ or organs the drugs affected, the ovaries and/or the anterior pituitary gland.

Format: Articles

Subject: Experiments

Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993)

In its 1993 decision Daubert v. Merrell Dow Pharmaceuticals, Inc., the US Supreme Court established the Daubert Standard for evaluating the admissibility of scientific knowledge as evidence in US federal courts. When it began in trial court, the case addressed whether or not Bendectin, an anti-nausea medication taken during pregnancy, caused birth defects. However, after the trial court dismissed the case for lack of admissible evidence, Daubert v. Merrell Dow Pharmaceuticals, Inc.

Format: Articles

Subject: Legal

Sindell v. Abbott Laboratories (1980)

Sindell v. Abbott Laboratories was a 1980 California case that established the doctrine of market share liability for personal injury cases. For such liability, when a drug causes personal injury and the manufacturer of the drug cannot be identified, each producer is responsible for paying the settlement in proportion to the percentage of the market they supplied. Judith Sindell and Maureen Rogers brought the case against the producers of diethylstilbestrol (DES), which their mothers had taken during pregnancy to prevent miscarriage and other complications.

Format: Articles

Subject: Legal

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