UPDATED: CDER Agenda Foreshadows Release of Guidances Long Sought by Industry
The Center for Drug Evaluation and Research (CDER), the US Food and Drug Administration's (FDA) primary drug regulatory body for chemical and biological drugs, has released a comprehensive list of all guidance documents it plans to release during the 2013 calendar year, including many long-awaited by the pharmaceutical and biopharmaceutical industries.
Update (8 March 2013): FDA regulators have added three new guidance documents set to be released by CDER in the coming year. The 8 March 2013 release includes Standards for Clinical Trial Imaging Endpoints, Clinical Lactation Trials - Trial Design, Data Analysis and Recommendations for Labeling and Pharmacokinetics During Pregnancy and the Postpartum Period - Trial Design, Data Analysis, and Impact on Dosing and Labeling.
Update II (29 July 2013): FDA regulators have made still more changes to the guidance list, deleting one proposed guidance while adding two others. The 29 July 2013 changes have deleted "Size and Physical Attributes of Generic Tablets" from the list, but have added "Pulmonary Tuberculosis: Developing Drugs for Treatment" and "Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs."
The 59 proposed guidance documents-new and revised documents in both final and draft form-fall into 17 distinct categories spanning clinical, advertising, safety, chemistry, bioequivalence and niche issues such as use of the animal rule.
One of the most notable guidance documents set to be released is one on biosimilarity (#4), which will reportedly detail the recommended submission format for pharmacology data used as evidence of biosimilarity. Another guidance (#50), will detail the expected process for formal meetings held between FDA and sponsors of 351(k) submissions.
Another notable document will include track and trace provisions for drug packaging (#34), provisions long called for by many in the industry but stalled over questions regarding its specifics. This provision would, it seems, apply only to the packaging of products, leaving open the question of whether the agency believes a lot-level or unit-level traceability level is preferable.
Two other guidance areas of importance include the use of electronic formats for regulatory submissions (#38-43, #59)-an area FDA said it hopes to soon require mandatory, instead of optional, submission for-and new guidance on pharmaceutical compounding (#54), which FDA has at times argued it lacks sufficient regulatory authority to issue.
Also of note are guidance documents on the inclusion of pregnant women (#16) and children (#25, #53), the development of rare disease therapies (#17), the rarely used animal rule pathway (#2), the size and physical attributes of generic tablet medications (#12), the use and modification of Risk Evaluation and Mitigation Strategies (REMS) plans (#18, #48, #58), the use of multiple endpoints in clinical trials (#26), a quality systems approach to pharmaceutical current good manufacturing practices (CGMP) (#27), and ways to reduce medication errors (#33, #36, #37).
The full list, organized for your convenience, may be found below.
Advertising | 1.) | Considerations for Regulatory Submissions of Promotional Labeling and Advertising Materials including Submissions in Electronic Format |
Animal Rule | 2.) | Product Development Under the Animal Rule |
Biopharmaceuticals | 3.) | Food-Effect Bioavailability and Fed Bioequivalence Studies---Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications General Consideration |
Biosimilarity | 4.) | Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products |
Chemistry | 5.) | Allowable Excess Volume and Labeled Vial Fill Size |
6.) | Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in Abbreviated New Drug Applications | |
7.) | CMC Postapproval Manufacturing Changes Reportable in Annual Reports for Specified Biological Products | |
8.) | Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information | |
9.) | Elemental Impurities in Drug Products Marketed in the United States | |
10.) | Immunogenicity Considerations for Low Molecular Weight Heparin | |
11.) | Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation | |
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Clinical/Antimicrobial | 13.) | Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment |
14.) | Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment | |
15.) | Antibacterial Therapies for Patients with Limited or No Alternative Therapies for the Treatment of Serious Bacterial Diseases | |
NEW | Pulmonary Tuberculosis: Developing Drugs for Treatment (Added 29 July 2013) | |
Clinical/Medical | 16.) | Pregnant Women in Clinical Trials - Scientific and Ethical Considerations |
17.) | Common Issues in Drug Development for Rare Diseases | |
18.) | Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS) | |
19.) | Alzheimer's Disease: Developing Drugs for the Treatment of Early State Disease | |
20.) | Developing Drug and Biological Products for Analgesic Indications | |
NEW | Standards for Clinical Trial Imaging Endpoints (Added 8 March 2013) | |
CMC & Clinical/Medical | 21.) | Immunogenicity Assessment for Therapeutic Protein Products |
Clinical Pharmacology | 22.) | Bioanalytical Methods Validation |
23.) | Clinical Pharmacogenomics: Study Design and Premarketing Evaluation | |
24.) | Clinical Pharmacology Consideration for Therapeutics Proteins | |
25.) | General Clinical Pharmacology Considerations for Pediatrics Studies for Drugs and Biological Products | |
NEW | Clinical Lactation Trials - Trial Design, Data Analysis and Recommendations for Labeling (Added 8 March 2013) | |
NEW | Pharmacokinetics During Pregnancy and the Postpartum Period - Trial Design, Data Analysis, and Impact on Dosing and Labeling (Added 8 March 2013) | |
Clinical/Statistical | 26.) | Multiple Endpoints in Clinical Trials |
Current Good Manufacturing Practices (CGMPs)/Compliance | 27.) | Quality Systems Approach to Pharmaceutical cGMP Regulation (OMPQ) |
28.) | Uniformity of In-Process Mixtures (OMPQ) | |
29.) | Control of Highly Potent Compounds (OMPQ) | |
30.) | Contract Manufacturing Arrangements for Drugs: Quality Agreements | |
31.) | Submission of Field Alert Reports and Biological Product Deviation Reports (OMPQ) | |
32.) | Pre-Launch Activities Importation Request (PLAIR) | |
Drug Safety Information | 33.) | Safety Considerations in Product Design to Minimize Medication Errors |
34.) | Securing the Drug Supply Chain-Standards for Tracking and Tracing Prescription Drug Packages | |
35.) | Providing Postmarket Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) | |
36.) | Safety Considerations for Container Label and Carton Labeling Design to Minimize Medication Errors | |
37.) | Best Practices in Developing Proprietary Names to Minimize Medication Errors | |
Electronic Submissions | 38.) | Providing Regulatory Submissions in Electronic Format - General Considerations |
39.) | Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications | |
40.) | Providing Regulatory Submissions in Electronic Format - Postmarketing Safety Reports | |
41.) | Providing Regulatory Submissions in Electronic Format - Standardized Study Data | |
42.) | Providing Submissions in Electronic Format - Summary Level Clinical Site Data for CDER's Inspection Planning | |
43.) | Providing Submissions in Electronic Format - Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers | |
Investigational New Drugs (INDs) | 44.) | Adverse Events: Collection and Reporting for Secondary Endpoints |
Labeling | 45.) | Drug Names and Dosage Forms |
46.) | Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling | |
Pharmacology/Toxicology | 47.) | Endocrine Disruption Potential of Drugs: Non Clinical Evaluation |
Procedural | 48.) | Applying the Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS) |
49.) | Expedited Programs for Serious Conditions, Drugs and Biologics | |
50.) | Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants | |
51.) | Integrated Summary of Safety | |
52.) | Investigational New Drug Applications prepared and submitted by Clinical Sponsor Investigators | |
53.) | Pediatric Product Development | |
54.) | Pharmacy Compounding of Human Drugs Under Section 503A of the Federal Food, Drug, and Cosmetic Act | |
55.) | Public Disclosure of FDA-Sponsored Studies | |
56.) | Prescription Drug Marketing Act (PDMA) Requirements | |
57.) | Reporting Drug Sample Distribution Under Section 6004 of the Affordable Care Act | |
58.) | Use of a Master File for Shared System Risk Evaluation and Mitigation Strategies | |
59.) | Electronic Source Data in Clinical Investigations | |
NEW | Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs (Added 29 July 2013) |
Note: This Article was originally published on 31 January 2013. It has since been updated to reflect changes in FDA's Guidance Agenda. Last update on 29 July 2013.