Word: fda
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...keeping of many more detailed records will be costly to all companies. The new law cannot be expected to lower the prices of any drugs, and may actually raise some by a few cents. Key provisions: > No new drug can be marketed until the manufacturer has satisfied the FDA that it is both safe and effective. Under the old law, only safety had to be proved, and approval was automatic after 60 days unless FDA took negative action. Under the new law, approval will not come automatically, and FDA must give positive approval. Even after a drug...
Before any drug is even tested in human beings, the manufacturer must give FDA evidence that it has had adequate testing in animals-this will include pregnant animals-and appears safe. > Every drug container, package, leaflet and advertisement to doctors must show the general or "established" name of the drug in type at least half as big as that of the trade name. Package inserts and ads to doctors must contain a warning of undesirable effects...
...Every batch of every antibiotic for use in man must be tested by government laboratories. Under the old law, some antibiotics were so tested, but not all. > Every plant in which a drug is manufactured or processed in any way will now have to be registered with FDA, inspected at least every two years, and open to inspection at any time...
...future, said Celebrezze, the rules for testing new drugs should be tightened to provide that: > Manufacturers give FDA full details about distribution of drugs to doctors for investigational use in human beings. > Human tests shall begin only after extensive animal tests, and then must be executed by qualified investigators. >Manufacturers must notify FDA and all investigators immediately if a substantial doubt develops about a drug's safety, and FDA should have the power to stop further trials of the drug...
...FDA, said the new Health Secretary, will issue such rules in about 60 days...