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Titles
- A sense of déjà vu: the debate surrounding state biosimilar substitution laws1
- Best practices for convening a GRAS panel: guidance for industry1
- Business practices1
- Compounding certain beta-lactam products in shortage under Section 503A of the Federal Food, Drug, and Cosmetic Act: immediately in effect guidance for industry1
- Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act1
- Cost savings2
- DSCSA standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs: guidance for industry1
- Definitions of suspect product and illegitimate product for verification obligations under the Drug Supply Chain Security Act: guidance for industry1
- Delays in confirmatory trials for drug applications granted FDA’s accelerated approval raise concerns1
- Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry1
- Direct-to-consumer prescription drug advertisements: presentation of the major statement in a clear, conspicuous, and neutral manner in advertisements in television and radio format final rule : questions and answers : guidance for industry1
- Drug safety: COVID-19 complicates already challenged FDA foreign inspection program : testimony before the Committee on Finance, U.S. Senate1
- Exemption and exclusion from certain requirements of the Drug Supply Chain Security Act for the distribution of FDA-approved naloxone products during the opioid public health emergency: guidance for industry1
- Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders1
- FDA Urged to Ban Drug Used in Effort to Bar Heart Attacks1
- FDA oversight1
- George P. Larrick: an oral history1
- Getting to the root of high prescription drug prices: drivers and potential solutions1
- Indiana Food, Drug, and Cosmetic Act1
- Jerome N. Sonosky: an oral history1