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Dec 20

New FDA Guidances for October and November 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in October and November 2017 are posted. Currently, there are no upcoming advisory committee meetings.

Special Interest Guidances/Information Date Posted
Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices – Draft Guidance 29 Nov 2017
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies – Draft Guidance 29 Nov 2017
Pediatric Information for X-ray Imaging Device Premarket Notifications – Final Guidance 28 Nov 2017
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier – Draft Guidance 27 Nov 2017
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products – Final Guidance 21 Nov 2017
Unique Device Identification: Direct Marking of Devices – Final Guidance 17 Nov 2017
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions – Draft Guidance 16 Nov 2017
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies – Draft Guidance 16 Nov 2017
Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception – Final Guidance 16 Nov 2017
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 – Draft Guidance 15 Nov 2017
S5(R3) Detection of Toxicity to Reproduction – Draft Guidance 09 Nov 2017
Use of a Drug Master File for Shared System REMS Submissions – Draft Guidance 08 Nov 2017
Evaluating Drug Effects on the Ability to Operate a Motor Vehicle – Final Guidance 08 Nov 2017
Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention – Final Guidance 06 Nov 2017
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment – Draft Guidance 06 Nov 2017
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery – Final Guidance 06 Nov 2017
Formal Dispute Resolution: Appeals Above the Division Level – Final Guidance 03 Nov 2017
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) – Draft Guidance 03 Nov 2017
Controlled Correspondence Related to Generic Drug Development – Draft Guidance 02 Nov 2017
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices – Final Guidance 30 Oct 2017
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials – Draft Guidance 30 Oct 2017
De Novo Classification Process (Evaluation of Automatic Class III Designation) – Final Guidance 30 Oct 2017
Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request – Final Guidance 30 Oct 2017
Acceptance Review for De Novo Classification Requests – Draft Guidance 30 Oct 2017
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 – Draft Guidance 27 Oct 2017
Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment – Draft Guidance 26 Oct 2017
In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies – Draft Guidance 25 Oct 2017
Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications – Draft Guidance 25 Oct 2017
Breakthrough Devices Program – Draft Guidance 25 Oct 2017
Deciding When to Submit a 510(k) for a Change to an Existing Device – Final Guidance 25 Oct 2017
Deciding When to Submit a 510(k) for a Software Change to an Existing Device – Final Guidance 25 Oct 2017
Salmeterol Xinafoate_020692 – Draft Guidance 18 Oct 2017
Fluticasone propionate_021433 – Draft Guidance 18 Oct 2017
Fluticasone propionate_020833 – Draft Guidance 18 Oct 2017
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA – Draft Guidance 13 Oct 2017
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 – Draft Guidance 12 Oct 2017
Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment – Draft Guidance 11 Oct 2017
Format and Content of a REMS Document – Draft Guidance 11 Oct 2017
Determining Whether to Submit an ANDA or a 505(b)(2) Application – Draft Guidance 11 Oct 2017
Requests for Reconsideration at the Division Level Under GDUFA – Draft Guidance 11 Oct 2017
ANDA Submissions – Prior Approval Supplements Under GDUFA – Final Guidance 04 Oct 2017
Completeness Assessments for Type II API DMFs Under GDUFA – Final Guidance 04 Oct 2017
Individual Patient Expanded Access Applications: Form FDA 3926 – Final Guidance 03 Oct 2017
M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Final Guidance 03 Oct 2017
Expanded Access to Investigational Drugs for Treatment Use — Qs & As – Final Guidance 03 Oct 2017
Waiver of IRB Requirements for Drug and Biological Product Studies – Information Sheet – Final Guidance 03 Oct 2017
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals – Final Guidance 02 Oct 2017
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff – Final Guidance 02 Oct 2017
User Fees and Refunds for Premarket Notification Submissions (510(k)s) – Final Guidance 02 Oct 2017
ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA – Draft Guidance 02 Oct 2017
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA – Draft Guidance 02 Oct 2017
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals – Final Guidance 02 Oct 2017
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals – Final Guidance 02 Oct 2017
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) – Draft Guidance 02 Oct 2017
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin – Draft Guidance 02 Oct 2017
User Fees for 513(g) Requests for Information – Final Guidance 02 Oct 2017
User Fees and Refunds for De Novo Classification Requests – Final Guidance 02 Oct 2017
ANDA Submissions – Refuse-to-Receive Standards: : Questions and Answers – Draft Guidance 02 Oct 2017
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers – Draft Guidance 02 Oct 2017
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications – Final Guidance 02 Oct 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
Prioritization of the Review of Original ANDAs, Amendments, and Supplements 09 Nov 2017
Developing and Issuing Drug Trial Snapshots 26 Oct 2017
CMC Reviews of Type III DMF’s for Packaging Materials 18 Oct 2017
Communicating Abbreviated New Drug Application Review Status Updates with Industry 06 Oct 2017
Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA 04 Oct 2017
Last updated: 15 December 2017