The regulatory framework for radioactive drugs, in particular those used in positron emission tomography (PET) scans, has been gradually established since the release of the Food and Drug Administration Modernization Act in 1997. Various guidances specially tailored to accommodate special properties of PET drugs have been issued by the Food and Drug Administration (FDA) in order to ensure this ...

The author of the above-mentioned paper would like to make the following adjustment to her article. In the last paragraph of the ‘Current Treatments’ section, the sentence currently reads ‘Lidocaine/tetracaine cream (Pliaglis , Galderma Laboratories, Texas, USA) is the first Food and Drug Administration (FDA)-approved stable compounded mixture of 7 % lidocaine and 7 % tetracaine cream.’ This se...

In 2003, the United States Food and Drug Administration (FDA) received a health claim petition for calcium supplements and reduced risk of colorectal, breast, and prostate cancers. Health claims characterize the relationship between a substance (food or food component) and disease (e.g., cancer or cardiovascular disease) or health-related condition (e.g., hypertension) and require premarket app...

Submit Manuscript | http://medcraveonline.com Abbreviations: DOACs: Direct Oral Anticoagulants; DVT: Deep Venous Thrombosis; PE: Pulmonary Embolus; PBS: Pharmaceutical Benefits Scheme; PD: Pharmacodynamic; PK: Pharmacokinetics; TGA: Therapeutic Good Administration; PCC: Prothrombin Complex Concentrate; PT: Prothrombin Time; aPTT: Activated Atrial Thromboplastin Time; FDA: Food and Drug Administ...

Agency: Food and Drug Administration, HHS. Action: Final Rule. __________________________ SUMMARY: The Food and Drug Administration (FDA) is announcing its decision not to authorize a health claim for folic acid and neural tube defects at this time. However, consistent with the recently announced recommendations of the U.S. Public Health Service (PHS) that all women of childbearing age in the U...

Most prescription drugs marketed in the United States have been reviewed and approved by the Food and Drug Administration as required by law. Thousands of unapproved prescription drugs, however, are still being prescribed and sold. The FDA, as part of its drug safety efforts, is bolstering its efforts against unapproved drugs in the United States.

Submit Manuscript | http://medcraveonline.com Abbreviations: ADME: Absorption, Distribution, Metabolism and Excretion; NDA: New Drug Application; FDA: Food and Drug Administration; CYP: Cytochrome P; UGT: Uridine DiphosphoGlucuronosyl Transferase; NAT: N-Acetyl Transferase; GST: Glutathione S-Transferase; ST: Sulfo Transferase; QSAR: Quantitative Structure–Activity Relationships; PCA: Principal...

Amyotrophic lateral sclerosis (ALS), also called Lou Gehrig’s disease, is a neuromuscular disease characterized by a progressive death of motor neurons and muscle atrophy. Most ALS patients die within 5 years of disease onset. Currently, treatment with the US Food and Drug Administration (FDA) approved drug, Riluzole, merely extends the patient’s life span for a few months. For the second time ...

Při kouření cigaret poškozuje zdraví především kouř, zplodiny spalování. Proto je poněkud překvapivé rozhodnutí americké Food and Drug Administration (FDA) z konce roku 2021 povolit filtrované cigarety s velmi nízkým obsahem nikotinu jakožto tabákové výrobky modifikovaným rizikem. Sníží se riziko vzniku a udržení závislosti, či zdravotní riziko?