Proton Pump Inhibitors - CME Conferences
Proton Pump Inhibitors - CME Conferences Proton Pump Inhibitors - CME Conferences
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 April 20, 2011 —A report from the IMS Institute for Healthcare Informatics • Small molecule spending totaled $240 billion,an increase of 0.5% as biologics grew by 6.6%, amounting to $67 billion. • Oral forms of medicines declined by 0.1%, but spending on injectables increased by 5.7%. FDA Regulation of Generic Drugs Office of Generic Drugs Center for Drug Evaluation and Research Wayne Weart, Pharm D Cost Effective Rx
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 FDA OGD Mission To ensure that safe and effective generic drugs are available to the American People. Center for Drug Evaluation and Research FDA Legislative History • 1906 Pure Food and Drug Act - establishes regulation of Food and Drugs. • 1938 Food, Drug and Cosmetic Act - introduced safety standards. • 1962 Kefauver-Harris Amendments to the FDA&C Act - tightened safety standards and introduced requirement that drugs must be effective. • 1984 Waxman-Hatch Act - created an abbreviated mechanism for approval of generic copies of all drugs approved approved after 1962, by stating that preclinical and clinical tests did not have to be repeated for generics. Center for Drug Evaluation and Research Wayne Weart, Pharm D Cost Effective Rx
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6 th Annual Primary Care Spring Conference Thursday, April 12, 2012<br />
April 20, 2011 —A report from the IMS Institute<br />
for Healthcare Informatics<br />
• Small molecule spending totaled $240<br />
billion,an increase of 0.5% as biologics grew<br />
by 6.6%, amounting to $67 billion.<br />
• Oral forms of medicines declined by 0.1%, but<br />
spending on injectables increased by 5.7%.<br />
FDA<br />
Regulation of Generic Drugs<br />
Office of Generic Drugs<br />
Center for Drug Evaluation and Research<br />
Wayne Weart, Pharm D<br />
Cost Effective Rx
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