« Previous
Next »
Titles
- E11(R1) addendum: clinical investigation of medicinal products in the pediatric population1
- E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)1
- E17 general principles for planning and design of multiregional clinical trials1
- E18 genomic sampling and management of genomic data1
- E6(R2) good clinical practice: integrated addendum to ICH E6(R1)1
- Elemental impurities in drug products1
- Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders1
- Emerging infectious diseases: actions needed to ensure improved response to Zika virus disease outbreaks : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives1
- Enforcement policy--OTC sunscreen drug products marketed without an approved application1
- Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products1
- Epidermolysis bullosa: developing drugs for treatment of cutaneous manifestations1
- Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders1
- Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff1
- Evaluating drug effects on the ability to operate a motor vehicle1
- Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff1
- Evaluation of devices used with regenerative medicine advanced therapies1
- Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers1
- Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders1
- Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)2