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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Prescription, Nonprescription and Orphan Drugs01:02

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Drug Products: Biologics, Biosimilars and Interchangeables01:28

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Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
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Catching Up on New Medications: New FDA Approvals.

Beatrice B Turkoski1

  • 1Beatrice B. Turkoski, RN, PhD, Professor Emeritus, Kent State University College of Nursing, Kent, OH.

Orthopedic Nursing
|January 28, 2016
PubMed
Summary

Nurses play a crucial role in educating patients about new drug approvals. Understanding new medications helps prevent harm from misinformation.

Area of Science:

  • Pharmacology and Nursing Education

Background:

  • Federal Drug Administration (FDA) drug approval information can be complex.
  • Media and marketing may present incomplete or misunderstood drug information.

Purpose of the Study:

  • To highlight the importance of nurses in patient education regarding new medications.
  • To discuss selected new drug approvals and first-time generics.

Main Methods:

  • Review of recent FDA-approved drugs.
  • Discussion of selected new brand name drugs and generics.

Main Results:

  • Nurses can clarify patient misunderstandings about new drugs.
  • Knowledgeable nurses reduce potential harm from medication misinformation.

Conclusions:

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  • Informed nurses are essential for safe patient medication management.
  • Patient education by nurses is vital for understanding new drug approvals.