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USFDA Guidance on Technical Performance Assessment of Quantitative Imaging in Radiological Device
According to the guidance document, FDA recommends what information should be included in a premarket submission for radiological devices...
Sharan Murugan
Jun 18, 20221 min read
ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) It is commonly understood...
Sharan Murugan
Jun 18, 20222 min read
USFDA Guidance - Assessment of the UI of a Drug-Device Combination - Pre-ANDA or ANDA Communication
FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product...
Sharan Murugan
Jun 16, 20221 min read
USFDA's Guidance of Electromagnetic Compatibility (EMC) of Medical Devices
On 3 June, USFDA's Center for Devices and Radiological Health & Center for Biologics Evaluation and Research released updated guidance...
Sharan Murugan
Jun 7, 20221 min read
USFDA- Q&A Guide on Importation of Prescription Drugs from Canada
Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription...
Sharan Murugan
May 26, 20221 min read
USFDA's Guidance on Risk Management Plans to Mitigate Drug Shortages
The USFDA recently released draft guidance intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to...
Sharan Murugan
May 22, 20221 min read
USFDA's Guidance on Safety Considerations for Container Labels and Carton Labeling
FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...
Sharan Murugan
May 22, 20221 min read
Generic Drug User Fee Guidance - Assessing User Fees - USFDA
The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections authorizing FDA to assess and collect user fees for a five-year...
Sharan Murugan
May 18, 20221 min read
USFDA Guidance - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
USFDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"....
Sharan Murugan
May 17, 20221 min read
USFDA Guidance on Product Quality Assessments - Benefit-Risk Considerations
Earlier on 9-May-2022, FDA announced that a draft guidance document was available to assist the industry regarding the Benefit-Risk...
Sharan Murugan
May 11, 20221 min read
USFDA: Activities and Engagement with the Voluntary Improvement Program
The FDA’s Center for Devices and Radiological Health (CDRH) is issuing this draft guidance to describe its policy regarding FDA’s...
Sharan Murugan
May 8, 20221 min read
USFDA Electronic Submission of IND Safety Reports - Technical Conformance Guide
This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...
Sharan Murugan
May 2, 20221 min read
USFDA Guidance on Electronic PostMarketing Safety Reporting
US Food and Drug Administration (FDA) finalized guidance for submitting postmarketing safety reports for drugs and biologics...
Sharan Murugan
May 2, 20221 min read
USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles
Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data On April 22 2022, USFDA, FDA has released the draft document,...
Sharan Murugan
Apr 24, 20221 min read
FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products
On April 13, 2022, FDA published new draft guidance for the industry entitled “Considerations for Waiver Requests for pH Adjusters in...
Sharan Murugan
Apr 17, 20221 min read
FDA's Bioavailability Guidance for NDAs or INDs- General consideration
The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...
Sharan Murugan
Apr 17, 20222 min read
FDA's MAPP on Complex Product Classification for Generic Development
On 13 April 2022, the FDA's Office of Generic Drugs (OGD) published a draft manual of policies and procedures, (MAPP 5240.10) outlining...
Sharan Murugan
Apr 17, 20221 min read
FDA Guidance:Providing Submissions in Electronic & Non-Elec Format—Promotional Labeling &Advertising
On 11-March-2022, FDA released the final guidance "Providing Regulatory Submissions in Electronic and Non-Electronic 1 Format —...
Sharan Murugan
Apr 13, 20222 min read
FDA's: OTC Monograph Drug User Fees for Fiscal Year 2022
Yesterday USFDA published the fees for over-the-counter (OTC) monograph drugs for fiscal year (FY) 2022 in a Federal Register Notice...
Sharan Murugan
Mar 15, 20221 min read
USFDA Guidance on Verification Systems & Voluntary Recalls
FDA is issuing this draft guidance "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance...
Sharan Murugan
Mar 13, 20221 min read