Overview of FDA Regulated Products
portes grátis
Overview of FDA Regulated Products
From Drugs and Cosmetics to Food and Tobacco
Pacifici, Eunjoo; Bain, Susan
Elsevier Science Publishing Co Inc
04/2025
330
Mole
9780443237805
Pré-lançamento - envio 15 a 20 dias após a sua edição
Descrição não disponível.
1. Introduction to regulated products
2. Regulatory authorities
3. Drugs
4. Biologics
5. Medical Devices and Diagnostics
6. Combination products, borderline products, and companion diagnostics
7. Foods and food additives
8. Veterinary products
9. Dietary supplements
10. Cosmetics
11. Tobacco products
12. Quality
13. Ensuring Medical Product Safety
2. Regulatory authorities
3. Drugs
4. Biologics
5. Medical Devices and Diagnostics
6. Combination products, borderline products, and companion diagnostics
7. Foods and food additives
8. Veterinary products
9. Dietary supplements
10. Cosmetics
11. Tobacco products
12. Quality
13. Ensuring Medical Product Safety
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
510(k); Abbreviated new drug application; Adverse events; Adverse reactions; Animal drugs; Animal feeds; Animal products; Animals; Benefit-risk management; Biologics; Biosimilars; Biotechnology; Blood products; Borderline products; CGMPs; CTP; Case management; Cell therapy; China NMPA; Clinical trial application; Combination products; Companion diagnostics; Cosmeceuticals; Cosmetic drugs; Cosmetics; Council for International Organization of Medical Sciences (CIOMS); De novo; Deeming Rule; Device classification; Devices; Dietary supplements; Drug; Drug and Cosmetic Act (FD&C Act); Drug development; European Union EMA; FDA Center for Tobacco Products; FSPTCA; Fair Packaging and Labeling Act (FPLA); Family Smoking Prevention and Tobacco Control Act; Federal Food; Federal Trade Commission (FTC); Food; Food and Drug Administration (FDA); GCP; GLP; GMP; Gene therapy; Generic drug; Good clinical practices; Good laboratory practices; Good manufacturing practices; IVD; International Council for Harmonisation (ICH); International Council on Harmonization (ICH); International Standards Organization (ISO); Investigational new drug; Japan MHLW; Japan PMDA; Laws; Marketing authorization application; Marketing authorization holder; Medical device; Medical devices; Medical product quality; Modernization of Cosmetics Regulation Act of 2022 (MoCRA); Monoclonal antibodies; New drug; New drug application; Office of combination products; Over-the-counter (OTC) drugs; Over-the-counter drug; PMA; Peptides; Pharmacovigilance; Postmarketing surveillance; Primary mode of action; Proteins; Quality; Quality systems; Regulation; Regulations; Regulatory structures; Request for designation; Responsible person; Signal management; Stem-cell therapy; Structure-function claims; TCA; Therapeutic claim; Tobacco; Tobacco Control Act; Tobacco Regulatory Science; Tobacco products; Tobacco regulation; US FDA; User fees; Vaccines; Veterinary products
1. Introduction to regulated products
2. Regulatory authorities
3. Drugs
4. Biologics
5. Medical Devices and Diagnostics
6. Combination products, borderline products, and companion diagnostics
7. Foods and food additives
8. Veterinary products
9. Dietary supplements
10. Cosmetics
11. Tobacco products
12. Quality
13. Ensuring Medical Product Safety
2. Regulatory authorities
3. Drugs
4. Biologics
5. Medical Devices and Diagnostics
6. Combination products, borderline products, and companion diagnostics
7. Foods and food additives
8. Veterinary products
9. Dietary supplements
10. Cosmetics
11. Tobacco products
12. Quality
13. Ensuring Medical Product Safety
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
510(k); Abbreviated new drug application; Adverse events; Adverse reactions; Animal drugs; Animal feeds; Animal products; Animals; Benefit-risk management; Biologics; Biosimilars; Biotechnology; Blood products; Borderline products; CGMPs; CTP; Case management; Cell therapy; China NMPA; Clinical trial application; Combination products; Companion diagnostics; Cosmeceuticals; Cosmetic drugs; Cosmetics; Council for International Organization of Medical Sciences (CIOMS); De novo; Deeming Rule; Device classification; Devices; Dietary supplements; Drug; Drug and Cosmetic Act (FD&C Act); Drug development; European Union EMA; FDA Center for Tobacco Products; FSPTCA; Fair Packaging and Labeling Act (FPLA); Family Smoking Prevention and Tobacco Control Act; Federal Food; Federal Trade Commission (FTC); Food; Food and Drug Administration (FDA); GCP; GLP; GMP; Gene therapy; Generic drug; Good clinical practices; Good laboratory practices; Good manufacturing practices; IVD; International Council for Harmonisation (ICH); International Council on Harmonization (ICH); International Standards Organization (ISO); Investigational new drug; Japan MHLW; Japan PMDA; Laws; Marketing authorization application; Marketing authorization holder; Medical device; Medical devices; Medical product quality; Modernization of Cosmetics Regulation Act of 2022 (MoCRA); Monoclonal antibodies; New drug; New drug application; Office of combination products; Over-the-counter (OTC) drugs; Over-the-counter drug; PMA; Peptides; Pharmacovigilance; Postmarketing surveillance; Primary mode of action; Proteins; Quality; Quality systems; Regulation; Regulations; Regulatory structures; Request for designation; Responsible person; Signal management; Stem-cell therapy; Structure-function claims; TCA; Therapeutic claim; Tobacco; Tobacco Control Act; Tobacco Regulatory Science; Tobacco products; Tobacco regulation; US FDA; User fees; Vaccines; Veterinary products
