Center for Biologics Evaluation and Research (U.S.)
Label
Center for Biologics Evaluation and Research (U.S.)
Name
Center for Biologics Evaluation and Research (U.S.)
Actions
Incoming Resources
- Guidance for industry, M3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals
- Guidance for industry, quality systems approach to pharmaceutical CGMP regulations
- Guidance for industry, qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act
- Guidance for indusry, integrated summary of effectiveness
- Guidance for industry, content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products
- Guidance for industry, eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps)
- Guidance for industry, reports on the status of postmarketing study commitments : implementation of section 130 of the Food and Drug Administration Modernization Act of 1997
- Guidance for industry, certain human cells, tissues and cellular and tissue-based products (HCT/Ps) recovered from donors who were tested for communicable diseases using pooled speciments or diagnostic tests
- Guidance for industry, collection of race and ethnicity data in clinical trials
- Guidance for industry, cooperative manufacturing arrangements for licensed biologics
- Guidance for industry, Q6B specifications : test procedures and acceptance criteria for biotechnological /biological products
- Guidance for industry, Q3B(R2) impurities in new drug products
- Guidance for industry, precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and their contacts
- Guidance for FDA reviews and sponsors, content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS)
- Guidance for industry, E 11 clinical investigation of medicinal products in the pediatric population
- Guidance for industry, Q3A impurities in new drug substances
- Guidance for industry, complementary and alternative medicine products and their regulation by the Food and Drug Administration
- Guidance for industry, year 2000 date change for computer systems and software applications used in the manufacture of blood products
- Guidance for industry, protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators
- Guidance for industry, M4, the CTD, general questions and answers
- Guidance for industry, implementing a collection program for source plasma containing disease-associated and other immunoglobulin G (IgG) antibodies
- Guidance for industry, Q1D bracketing and matrixing designs for stability testing of new drug substances and products
- Guidance for industry, an acceptable circular of information for the use of human blood and blood components
- Use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use
- Guidance for industry, Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for extractable volume of parenteral preparations general chapter
- User fees and refunds for premarket approval applications
- Bundling multiple devices or multiple indications in a single submission
- Guidance for industry, providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications
- Q8(R1) pharmaceutical development revision 1
- Guidance for industry, Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter
- Guidance for industry, Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process
- Guidance for industry, criteria for safety and efficacy evaluation of oxygen therapeutics as red blood cell substitutes
- Guidance for industry, how to complete the vaccine adverse event reporting system form (VAERS-1)
- Guidance for industry, clinical data needed to support the licensure of seasonal inactivated influenza vaccines
- Guidance for industry, Q1E evaluation of stability data
- Guidance for reviewers, potency limits for standardized dust mite and grass allergen vaccines, a revised protocol
- Premarket approval application filing review
- Annual reports for approved premarket approval applications (PMA)
- Guidance for industry, "computer crossmatch" (electronic based testing for the compatibility between the donor's cell type and the recipient's serum or plasma type)
- Guidance for industry, revised recommendations for the assessment of donor suitability and blood product safety in cases of suspected severe acute respiratory syndrome (SARS) or exposure to SARS
- Guidance for industry, bar code label requirements, questions and answers
- Guidance for industry, acceptance of foreign clinical studies
- Guidance for industry, MedWatch form FDA 3550A, mandatory reporting of adverse reactions related to human cells, tissues, and cellular and tissue-based products (HCT/Ps)
- Guidance for industry, granularity document : annex to M4, organization of the CTD
- Guidance for industry, consumer-directed broadcast advertisements, questions and answers
- Guidance for industry, blood establishment computer system validation in the user's facility
- Guidance for industry, process validation, general principles and practices
- Guidance for industry, Q7A good manufacturing practice guidance for active pharmaceutical ingredients
- Q4B, annex 2, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Guidance for industry, providing regulatory submissions in electronic format, general considerations
- Focus of1