Skip to main content .

Guidance

Guidance

Emergency Preparedness and Response

  • Emergency Use Authorization (HTML)
  • Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) (HTML)
  • (PAHPRA) FDA Questions and Answers for Public Health Preparedness and Response Stakeholders-January 2014 (HTML)
  • Administrative Procedures for Emergency Use Authorization of Medical Products (Vaccines, Blood and Biologics--CBER) (HTML)

Guidance

Drugs

  • Drug Development and Approval Process (HTML)
  • Forms & Submission Requirements (HTML)
  • Development Resources (HTML)
  • Antibacterial Drug Development Taskforce (HTML)
  • Pre-IND Consultation Program (Office of Antimicrobial Products) (HTML)
  • Drug Development Tools (DDT) Qualification Programs (HTML)
  • How Drugs are Developed and Approved (HTML)
  • Clinical Trials (HTML)
  • cGMP Manufacturing (HTML)
  • CDER Small Business and Industry Assistance (CDER SBIA) (HTML)

Guidance

Vaccines, Blood and Biologics

  • Development & Approval Process (CBER) (HTML)
  • Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER) (HTML)
  • Manufacturer and Industry Assistance and Resources (CBER) (HTML)
  • Regulatory Submissions in Electronic Format for Biologic Products (HTML)

Guidance

Devices

  • Device Advice: Comprehensive Regulatory Assistance (HTML)
  • CDRH Learn (HTML)
  • How to Market Your Device (HTML)
  • IVD Regulatory Assistance (HTML)
  • eCopy Program for Medical Device Submissions (HTML)

Guidance

Animal Rule

Guidance

Good Laboratory Practices

  • Questions & Answers - Good Laboratory Practice Regulations (HTML)
  • Nonclinical Laboratories Inspected under Good Laboratory Practices (HTML)
  • The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff (HTML)

Guidance

Technology Readiness Levels

Guidance

Guidance Regarding Specific Types of Medical Countermeasures

  • CDER DRAFT Guidance: Inhalational Anthrax (Post-Exposure) - Developing Antimicrobial drugs. March 2002. (PDF - 41KB)
  • CDER DRAFT Guidance: Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination. March 2004. (PDF - 138 KB)
  • CDER Guidance: Internal Radioactive Contamination-Development of Decorporation Agents FINAL Guidance. March 2006. (PDF - 176KB)
  • Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (HTML)
  • Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines (HTML)
  • Use of Masks During a Pandemic (HTML)
  • Personal Protective Equipment and Patient Care (HTML)

Guidance

Acquisition Regulations

  • Federal Acquisition Regulations (FAR) (HTML): The Federal Acquisition Regulations System is established for the codification and publication of uniform policies and procedures for acquisition by all executive agencies. The Federal Acquisition Regulations System consists of the Federal Acquisition Regulation (FAR), which is the primary document, and agency acquisition regulations that implement or supplement the FAR. The FAR System does not include internal agency guidance of the type described in 1.301(a)(2).
  • HHS Acquisition Regulation (HHSAR) (HTML) The Department of Health and Human Services Acquisition Regulation (HHSAR) is issued to establish uniform acquisition policies and procedures for the Department of Health and Human Services (HHS) which conform to the Federal Acquisition Regulation (FAR) System. The HHSAR implements and supplements the FAR. (Implementing material expands upon or indicates the manner of compliance with related FAR material. Supplementing material is new material which has no counterpart in the FAR.) The HHSAR contains all formal departmental policies and procedures that govern the acquisition process or otherwise control contracting relationships between the Department 's contracting offices and contractors.

Website Refresh

www.medicalcountermeasures.gov is pleased to announce a phased launch of our newly redesigned public website. We are making website improvements to provide a more modern and customer-centric web experience. Over the next several months you will see differences throughout the site while we continue implementing updates. Thank you for your understanding and please let us know if you have any questions: mailto:techwatchinbox@hhs.gov