Mon-Sun: 9.00 AM - 6.00 PM
+919696097866 /+912512400397

USFDA Regulatory Guidance Updates

USFDA Regulatory Guidance Updates

USFDA has released about 34 documents in the month of January and February 2017 out of these only 6 have been finalized rest 28 are draft version only.

Final guidance document for cGMP for combination products – January 9, 2017

In this document FDA has described the final rule on cGMP requirements for combination products which FDA has issued on January 22, 2013. This guidance documents enables guidelines for manufacturing of combination products. Although guidance was released there was no new requirements established in cGMP. It was only intended to clarify which cGMP requirements apply when drugs, devices and biological products are combined to create combination products. In section II of this document FDA has defined combination product. Section V analyzes hypothetical conditions that illustrate compliance with cGMP

Recommendation and assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus – January 10, 2017

FDA has notified blood donor eligibility and blood product management in response to Ebola virus. This guideline is only recommendation not requirements. This guidance document applies to routine collection of blood and blood components.

FDA is notifying you that blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma; FDA does not have any legal responsibilities for them. Instead, guidance describes the FDA’s current thinking on a topic and should be viewed only as recommendations.

Guidance for Nonproprietary Naming of Biological Products – January 12, 2017

FDA provides guidance on naming of biological products which are non-proprietary and need for biological products licensed under Public Health Service (PHS) act. In the naming of biological product licensed under PHS act should contain FDA-designed suffix. Under this naming convention the name shall contain proper name which is combination of core name and a distinguishing suffix that is without meaning and composed of four lowercase letters.

Guidance for Mixing, Diluting, or Repackaging Biological Products outside the Scope of an Approved Biologics License Application – January 12, 2017.

In this guidance document FDA has set policy regarding Mixing, Diluting, or Repackaging Biological Products licensed under PHS act 351. This document is specifically for those biological products that are not within the scope of approved biological licensed applications (BLA). FDA has stated conditions for which FDA is not intended to take action for violation of PHS act 351 when a state-licensed pharmacy, federal facility or outsourcing facility dilutes mixes or repacks biological products outside the scope of BLA.

Abuse potential of drugs – January 17, 2017.

In this document USFDA has stated that if a drug has any effect on CNS then it will have to undergo controlled substances act (CSA). USFDA has divided drugs into five schedules i.e. I, II, III, IV and V. A drug which is not accepted medical use and have lack of safety for use is included in Schedule I, drugs that do have a currently accepted medical use i.e. FDA approved drugs are placed into schedule II, III, IV or V. Contents of Schedule II-V are determined by relative abuse potential of the drug or substance and relative degree.

Regulations of mosquito related products – January 19, 2017.

This guidance provides information for industry and other stakeholders regarding regulatory oversight of articles, including substances, for use in or on mosquitoes i.e. mosquito related substances. These products are regulated by FDA as new animal drugs under FD & C act. These entire mosquito related products everyone should be registered as a new animal drug.

Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act – February 16, 2017

This guidance addresses the compliance of trading partners that engage in transactions with first responders with the requirement for conducting business only with authorized trading partners. Exchange of product tracing information took effects on July 1, 2015 for dispensers.

This guidance describes FDA’s compliance policy regarding certain requirements in section 582 of the FD & C Act for transactions with first responders. FDA does not intend to take action against a dispenser who transfers ownership of product without providing tracing information to first responder. FDA also does not intend to take action against trading partners who conduct business first responder that is not “authorized” as a dispenser.


Subscribe to our newsletter:

1 Comment

  • IPNU Dr. Charmy S. Kothari Posted April 3, 2017 6:20 PM

    Very informative

Add Your Comment

Your email address will not be published. Required fields are marked *

The technical inputs, quality of work and translation output provided by M/s. InClinition, Dombivli, Mumbai, India were found satisfactory and meeting the latest standards. We recommend them for any kind of translation projects in future.

Dr. Ashish Mungantiwar
Dr. Ashish MungantiwarPresident-Medical Services, Mcleods Pharmaceuticals Ltd.

We found their suggestions and guidelines appropriate to our formulation range. InClinition Team has expert domain knowledge. They involved all our staff during conduction of audit and created positive approach towards audit. We strongly recommend their services and wish a continued support from them.

Mr. Nandkishor Deshpande
Mr. Nandkishor DeshpandeDirector, Debco Homeopathic Pharmaceuticals

On occasion of InClinition's 1st International Scientific Conference, we wish a grand success to conference.

Mr. Pranab Mukherjee
Mr. Pranab MukherjeePresident, Republic of India
Phone: +919696097866 /+912512400397
Corporate office: 91Springboard Lotus, Plot No.5, Road No.20, Marol MIDC, Andheri (East)-400069, Mumbai, India
Registered Office: S2/3, Shri Devdoot, Phule Road, Dombivli (West), Mumbai, India