Tag: usfda

New FDA Guidance on the Finalization of several FDA Draft Guidances

https://seetharamkandarpa.webnode.in/news/new-fda-guidance-on-the-finalization-of-several-fda-draft-guidances/

FDA Inspection Reports: What are various results and their significance?

https://seetharamkandarpa.webnode.in/news/fda-inspection-reports-what-are-various-results-and-their-significance-/

U.S. FDA Clearance for Mass Spectrometry

https://seetharamkandarpa.webnode.in/news/u-s-fda-clearance-for-mass-spectrometry/

Cleaning Validation Requirements in Asia

https://seetharamkandarpa.webnode.in/news/cleaning-validation-requirements-in-asia/

USFDA increases inspection staff in India

https://seetharamkandarpa.webnode.in/news/usfda-increases-inspection-staff-in-india/

USFDA Draft Guidance - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection

https://seetharamkandarpa.webnode.in/news/usfda-draft-guidance-circumstances-that-constitute-delaying-denying-limiting-or-refusing-a-drug-inspection/

FDA Warning for Inadequate Storage of Reference Samples and Reagents

https://seetharamkandarpa.webnode.in/news/fda-warning-for-inadequate-storage-of-reference-samples-and-reagents/

European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach

https://seetharamkandarpa.webnode.in/news/european-medicines-agency-and-us-food-and-drug-administration-release-further-guidance-on-quality-by-design-approach/

FDA published List of GMP facilities producing for the US market (generic drug products and APIs)

https://seetharamkandarpa.webnode.in/news/fda-published-list-of-gmp-facilities-producing-for-the-us-market-generic-drug-products-and-apis-/

New FDA Requirement on the Handling of INDs

https://seetharamkandarpa.webnode.in/news/new-fda-requirement-on-the-handling-of-inds1/

More Inspections by USFDA in 2014

https://seetharamkandarpa.webnode.in/news/more-inspections-by-usfda-in-2014/

My new Mobile Application "SRK GCP World"

https://seetharamkandarpa.webnode.in/news/my-new-mobile-application-srk-gcp-world/

New Guidance on Validation of Analytical Methods by USFDA

https://seetharamkandarpa.webnode.in/news/new-guidance-on-validation-of-analytical-methods-by-usfda/

FDA Secure Supply Chain Pilot Program: 13 companies prequalified

https://seetharamkandarpa.webnode.in/news/fda-secure-supply-chain-pilot-program-13-companies-prequalified/

FDA wants to increase Number of foreign Inspections

https://seetharamkandarpa.webnode.in/news/fda-wants-to-increase-number-of-foreign-inspections/

Overview of new CDRH Guidelines

https://seetharamkandarpa.webnode.in/news/overview-of-new-cdrh-guidelines/

FDA plans Changes to the Classification of Medical Devices

https://seetharamkandarpa.webnode.in/news/fda-plans-changes-to-the-classification-of-medical-devices/

FDA published Medical Device Recall Report

https://seetharamkandarpa.webnode.in/news/fda-published-medical-device-recall-report/

FDA published Guidance for Industry on "Investigation Device Exemptions (IDE)"

https://seetharamkandarpa.webnode.in/news/fda-published-guidance-for-industry-on-investigation-device-exemptions-ide-/

Electronic Submissions Presentations by USFDA

https://seetharamkandarpa.webnode.in/news/electronic-submissions-presentations-by-usfda/

US FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products and FDA Questions and Answers

https://seetharamkandarpa.webnode.in/news/us-fda-guidance-for-industry-andas-stability-testing-of-drug-substances-and-products-and-fda-questions-and-answers/

EMA Official Details Obstacles to Reaching Mutual Reliance on GMP Inspections

https://seetharamkandarpa.webnode.in/news/ema-official-details-obstacles-to-reaching-mutual-reliance-on-gmp-inspections/

Sun Pharma gets warning letter from USFDA

https://seetharamkandarpa.webnode.in/news/sun-pharma-gets-warning-letter-from-usfda/

Particles continue to cause major compliance problems and recalls

https://seetharamkandarpa.webnode.in/news/particles-continue-to-cause-major-compliance-problems-and-recalls/

FDA launches openFDA to provide easy access to valuable FDA public data

https://seetharamkandarpa.webnode.in/news/fda-launches-openfda-to-provide-easy-access-to-valuable-fda-public-data/

India's Data Integrity Problems

https://seetharamkandarpa.webnode.in/news/indias-data-integrity-problems/

Regulators Again Find Data Integrity Problems at Indian Manufacturing Site

https://seetharamkandarpa.webnode.in/news/regulators-again-find-data-integrity-problems-at-indian-manufacturing-site/

USFDA Warning Letter to Novacyl Wuxi Pharmaceutical Co., Ltd. 12/19/14

https://seetharamkandarpa.webnode.in/news/usfda-warning-letter-to-novacyl-wuxi-pharmaceutical-co-ltd-12-19-14/

USFDA Inspections/483s Dashboard

https://seetharamkandarpa.webnode.in/news/usfda-inspections-483s-dashboard/

USFDA 483s Published in 2014 by USFDA

https://seetharamkandarpa.webnode.in/news/usfda-483s-published-in-2014-by-usfda/

USFDA Warning Letters- Drugs Updates

https://seetharamkandarpa.webnode.in/news/usfda-warning-letters-updates/

New Guidance on Environmental Assessments for Biotechnology Products by USFDA

https://seetharamkandarpa.webnode.in/news/new-guidance-on-environmental-assessments-for-biotechnology-products-by-usfda/

FDA warns consumers not to use muscle growth product called Tri-Methyl Xtreme

https://seetharamkandarpa.webnode.in/news/fda-warns-consumers-not-to-use-muscle-growth-product-called-tri-methyl-xtreme/

FDA's New Pharmaceutical Quality Approach- One Quality Voice

https://seetharamkandarpa.webnode.in/news/fdas-new-pharmaceutical-quality-approach-one-quality-voice/

U.S. Marshals seize unapproved drugs from Florida distributor

https://seetharamkandarpa.webnode.in/news/u-s-marshals-seize-unapproved-drugs-from-florida-distributor/

USFDA Guidance on "ANDA Submissions- Refuse-to-Receive Standards" Effective from 26 May 2015

https://seetharamkandarpa.webnode.in/news/usfda-guidance-on-anda-submissions-refuse-to-receive-standards-effective-from-26-may-2015/

USFDA Draft Guidance on "Conditions: Reportable CMC Changes for Approved Drug and Biologic Products" Effective from 29 May 2015

https://seetharamkandarpa.webnode.in/news/usfda-draft-guidance-on-conditions-reportable-cmc-changes-for-approved-drug-and-biologic-products-effective-from-29-may-2015/

New Draft Guidance from USFDA on 'Request for Quality Metrics

https://seetharamkandarpa.webnode.in/news/new-draft-guidance-from-usfda-on-request-for-quality-metrics/

New final Guidance from USFDA related to Pharmaceutical Quality/CMC on 'Analytical Procedures and Methods Validation for Drugs and Biologics

https://seetharamkandarpa.webnode.in/news/new-final-guidance-from-usfda-related-to-pharmaceutical-quality-cmc-on-analytical-procedures-and-methods-validation-for-drugs-and-biologics/

USFDA published a final rule (FDA-2011-N-0898 Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products)

https://seetharamkandarpa.webnode.in/news/usfda-published-a-final-rule-fda-2011-n-0898-permanent-discontinuance-or-interruption-in-manufacturing-of-certain-drug-or-biological-products/

Quality Metrics: Industry Reaction to FDA's Draft Guidance

https://seetharamkandarpa.webnode.in/news/quality-metrics-industry-reaction-to-fdas-draft-guidance/

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy

https://seetharamkandarpa.webnode.in/news/fda-allows-marketing-of-first-direct-to-consumer-app-for-contraceptive-use-to-prevent-pregnancy/

FDA issues final guidance entitled Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances

https://seetharamkandarpa.webnode.in/news/fda-issues-final-guidance-entitled-dissolution-testing-and-acceptance-criteria-for-immediate-release-solid-oral-dosage-form-drug-products-containing-high-solubility-drug-substances/

FDA Launches New Medication Guide Database - Drug Information Update

https://seetharamkandarpa.webnode.in/news/fda-launches-new-medication-guide-database-drug-information-update/

cGMP Guidelines

https://seetharamkandarpa.webnode.in/products/product-1/