The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk; every drug has specific information listed in its product literature. The British National Formulary used to provide a table of drugs to be avoided or used with caution in pregnancy, did so using a limited number of key phrases, but now Appendix 4 has been removed. Appendix 4 is now titled "Intravenous Additives". However, information, available in the former Appendix 4 and Appendix 5 is now available in the individual drug monographs. American law requires that certain drugs and biological products must be labelled specifically. Title 21, Part 201.57 of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category".
These rules are enforced by the Drug Administration. To supplement this information, FDA publishes additional rules regarding pregnancy and lactation labeling; the FDA does not regulate labeling for all non-hazardous substances. Many substances, including alcohol, are known to cause serious hazards to pregnant women and their fetus, including fetal alcohol syndrome. Many other pollutants and hazardous materials are known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57. One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A; as a result of this, many drugs that would be considered Pregnancy Category A in other countries are allocated to Category C by the FDA. On December 13, 2014, the FDA published the Pregnancy and Lactation Labeling Final Rule, which changed the labeling requirements for the pregnancy and lactation sections for prescription drugs and biological agents.
The final rule removed the pregnancy letter categories, created descriptive subsections for pregnancy exposure and risk and effects to reproductive potential for females and males. Labeling changes from this rule began on June 30, 2015, with all submissions for prescription drugs and biological agents using the labeling changes immediately. Approved drugs from June 30, 2001 will switch to the new labeling gradually; the rule does not affect the labeling of over-the-counter drugs. Australia has a different pregnancy category system from the United States – notably the subdivision of Category B.. The system, as outlined below, was developed by medical and scientific experts based on available evidence of risks associated with taking particular medicines while pregnant. Being general in nature it is not presented as medical advice to the public; some prescribing guides, such as the Australian Medicines Handbook, are shifting away from using pregnancy categories since, inherent in these categories, there is an implied assumption that the alphabetical code is one of safety when this is not always the case.
Categorisation does not indicate which stages of fetal development might be affected and does not convey information about the balance between risks and benefits in a particular situation. Additionally, categories are not maintained or updated with availability of new data; the data presented is for comparative and illustrative purposes only, may have been superseded by updated data. "Why poison your baby?". Prn2.usm.my. Archived from the original on 2003-05-17. Medicines in Pregnancy Working Party. "Prescribing medicines in pregnancy". Australian Drug Evaluation Committee. Archived from the original on 2007-06-05. Retrieved 2008-05-21. – links provided for 1999 4th edition and subsequent updates Sannerstedt, R.. "Drugs during pregnancy: an issue of risk classification and information to prescribers". Drug Saf. 14: 69–77. Doi:10.2165/00002018-199614020-00001. PMID 8852521. Food and Drug Administration. Federal Register 1980. Labeling Requirements for Prescription Drugs and/or Insulin. Food and Drug Administration.
April 1, 1997. Archived from the original on 2008-03-26. Retrieved 2008-05-21
Intermediate 2 level is Level 5 on the Scottish Credit and Qualifications Framework. It was available to pupils who achieved a grade 3 or 4 Standard Grade but, with some schools choosing to use Intermediates over Standard Grade, it is now more available to S3/S4 pupils, it is believed that in certain subjects Intermediates are more useful to the students than Standard Grades because the work required for completion is more demanding, better prepares the pupils for Higher, with a similar format to the reformed higher exams. Furthermore, the pupils are introduced to Higher work before they have sat their Intermediate 2 exam which makes the transition easier; the Intermediate 2 courses are made up of 3 national units, the main exceptions are English and French, with mandatory internal assessments in each. The courses all consist of 40 hours. Mandatory passes are needed in the internal assessments or NAB's National Assessment Bank to gain the overall Course Award; however internal assessments are minimum competence, so many schools have introduced end-of-unit assessments to help stop complacency.
As with other exams in the Higher Still curriculum, the grades pupils can receive in the final exam are A, B, a C, a D or a Fail. Pupils sit for preparatory examinations before the final examinations administered in December or January; these examinations are conducted under final examination conditions, containing more challenging content than the final examination and help prepare students. The next level of education provided in Scotland are the "Highers" Up until the summer of 2015, Intermediate 2 was a level of qualification certificated by the Scottish Qualifications Authority, it is no longer available and has been replaced by a new qualification level called "National 5"
Norden Eh Huang is a Chinese-American Fluid dynamist known for the Hilbert–Huang transform. Huang was born in Hubei, China in 1937, he attended Hsinchu Senior High School and graduated from National Taiwan University in 1960 before earning a doctorate in fluid mechanics and mathematics from Johns Hopkins University in 1967. He completed postdoctoral research at the University of Washington held adjunct professorships at the University of Delaware and University of North Carolina while working for NASA. Huang returned to Taiwan and began teaching at National Central University in 2006, as K. T. Lee and TSMC Chair Professor. Huang was elected a member of the United States National Academy of Engineering in 2000, Taiwan's Academia Sinica in 2004, a foreign member of the Chinese Academy of Engineering in 2007