Tag: FDA

FDA publishes GMP Requirements for "Combination Products"

https://seetharamkandarpa.webnode.in/news/fda-publishes-gmp-requirements-for-combination-products/

Comparison of EU GMP and Indian GMP Requirements for APIs

https://seetharamkandarpa.webnode.in/news/comparison-of-eu-gmp-and-indian-gmp-requirements-for-apis/

FDA offers eLearning for eCTD Implementation

https://seetharamkandarpa.webnode.in/news/fda-offers-elearning-for-ectd-implementation/

Ranbaxy pleads guilty and pays $500 million fine

https://seetharamkandarpa.webnode.in/news/ranbaxy-pleads-guilty-and-pays-500-million-fine-/

FDA addresses retention of Internal Audit Reports

https://seetharamkandarpa.webnode.in/news/fda-addresses-retention-of-internal-audit-reports/

FDA Answers Questions related to User Fees for Generic Drugs

https://seetharamkandarpa.webnode.in/news/fda-answers-questions-related-to-user-fees-for-generic-drugs/

FDA 483 Observation caused by wrong SOP for Method Transfer

https://seetharamkandarpa.webnode.in/news/fda-483-observation-caused-by-wrong-sop-for-method-transfer/

FDA Two new Q&As published for Investigational Drugs

https://seetharamkandarpa.webnode.in/news/fda-two-new-q-as-published-for-investigational-drugs/

Half-year Report 2013: FDA Medical Devices Warning Letter Statistics - 2 New Deficiency Group in the Top 5

https://seetharamkandarpa.webnode.in/news/half-year-report-2013-fda-medical-devices-warning-letter-statistics-2-new-deficiency-group-in-the-top-5/

Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

https://seetharamkandarpa.webnode.in/news/biological-products-human-blood-and-blood-components-intended-for-transfusion-or-for-further-manufacture/

New FDA Guideline on Quality of Heparin

https://seetharamkandarpa.webnode.in/news/new-fda-guideline-on-quality-of-heparin/

New Requirements of the FDA on Stability Testing of Generic Drugs

https://seetharamkandarpa.webnode.in/news/new-requirements-of-the-fda-on-stability-testing-of-generic-drugs/

Denying, Delaying, And Refusing: How to Fail a FDA Inspection

https://seetharamkandarpa.webnode.in/news/denying-delaying-and-refusing-how-to-fail-a-fda-inspection/

PLAIR - new FDA Guideline regulates Import of non-approved Drugs in the Run-Up to the Launch in US

https://seetharamkandarpa.webnode.in/news/plair-new-fda-guideline-regulates-import-of-non-approved-drugs-in-the-run-up-to-the-launch-in-us/

FDA Releases Guidance on Quality Agreements for Contract Manufacturing

https://seetharamkandarpa.webnode.in/news/fda-releases-guidance-on-quality-agreements-for-contract-manufacturing/

FDA issues Guidance for Industry on Risk-Based Monitoring

https://seetharamkandarpa.webnode.in/news/fda-issues-guidance-for-industry-on-risk-based-monitoring/

FDA’s Special Agents: Criminal Investigators

https://seetharamkandarpa.webnode.in/news/fdas-special-agents-criminal-investigators/

New Draft Guidance - Cosmetic Good Manufacturing Practices

https://seetharamkandarpa.webnode.in/news/new-draft-guidance-cosmetic-good-manufacturing-practices/

Incredible and Alarming GMP Violations

https://seetharamkandarpa.webnode.in/news/incredible-and-alarming-gmp-violations-/

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-/

FDA publishes Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility

https://seetharamkandarpa.webnode.in/news/fda-publishes-guidance-for-industry-blood-establishment-computer-system-validation-in-the-users-facility/

FDA Publishes Guidance on Clinical Trials

https://seetharamkandarpa.webnode.in/news/fda-publishes-guidance-on-clinical-trials/

New FDA Guidelines for Medical Devices

https://seetharamkandarpa.webnode.in/news/new-fda-guidelines-for-medical-devices/

FDA Guide on Import of Drugs prior to approval

https://seetharamkandarpa.webnode.in/news/fda-guide-on-import-of-drugs-prior-to-approval/

U.S. Government Shutdown: Consequences for the FDA

https://seetharamkandarpa.webnode.in/news/u-s-government-shutdown-consequences-for-the-fda/

FDA Scientists link transfused UVB irradiated platelets with acute lung injury

https://seetharamkandarpa.webnode.in/news/fda-scientists-link-transfused-uvb-irradiated-platelets-with-acute-lung-injury/

New FDA Requirements on Labelling and Container Labels

https://seetharamkandarpa.webnode.in/news/new-fda-requirements-on-labelling-and-container-labels/

New FDA Requirement on the Handling of INDs

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

FDA publishes current list of Drug Master Files (Type II)

https://seetharamkandarpa.webnode.in/news/fda-publishes-current-list-of-drug-master-files-type-ii-/

FDA publishes revised Guidance for Applicants of Marketing Authorisations for Generics

https://seetharamkandarpa.webnode.in/news/fda-publishes-revised-guidance-for-applicants-of-marketing-authorisations-for-generics/

FDA published Guideline Draft on the Registration of Production Sites

https://seetharamkandarpa.webnode.in/news/fda-published-guideline-draft-on-the-registration-of-production-sites/

Authorisation of Generic Drugs in the USA: Requirements on APIs Stability Data for US Drug Master Files

https://seetharamkandarpa.webnode.in/news/authorisation-of-generic-drugs-in-the-usa-requirements-on-apis-stability-data-for-us-drug-master-files/

Stability Testing of Generics: FDA publishes Q&A Document

https://seetharamkandarpa.webnode.in/news/stability-testing-of-generics-fda-publishes-q-a-document/

FDA Launched Secure Supply Chain Pilot Program

https://seetharamkandarpa.webnode.in/news/fda-launched-secure-supply-chain-pilot-program/

New FDA Fees for Drug Master Files published

https://seetharamkandarpa.webnode.in/news/new-fda-fees-for-drug-master-files-published/

FDA is proposing a regulation to implement administrative detention authority during inspections

https://seetharamkandarpa.webnode.in/news/fda-is-proposing-a-regulation-to-implement-administrative-detention-authority-during-inspections/

FDA Science and Research: Keeping stored platelets free of bacteria

https://seetharamkandarpa.webnode.in/news/fda-science-and-research-keeping-stored-platelets-free-of-bacteria/

FDA publishes Guidance for Industry on "Investigation Device Exemptions"

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

FDA will participate in a Medical Devices Single Audit Pilot Programme in 2014

https://seetharamkandarpa.webnode.in/news/fda-will-participate-in-a-medical-devices-single-audit-pilot-programme-in-2014/

Updates on Medical Device Regulations

https://seetharamkandarpa.webnode.in/news/updates-on-medical-device-regulations/

Boston Scientific's Watchman stroke-fighting device wins overwhelming FDA panel support

https://seetharamkandarpa.webnode.in/news/boston-scientifics-watchman-stroke-fighting-device-wins-overwhelming-fda-panel-support/

Most Frequent FDA 483 Observations Fiscal Year 2012

https://seetharamkandarpa.webnode.in/news/most-frequent-fda-483-observations-fiscal-year-2012/

FDA 2013 Review

https://seetharamkandarpa.webnode.in/news/fda-2013-review/

"Reception denied!" - the new FDA "Refuse-to-Receive" Guidance for Generics Applications

https://seetharamkandarpa.webnode.in/news/reception-denied-the-new-fda-refuse-to-receive-guidance-for-generics-applications/

GCP and Bioequivalence Studies: new FDA/EMA Initiative

https://seetharamkandarpa.webnode.in/news/gcp-and-bioequivalence-studies-new-fda-ema-initiative/

New FDA Guidance for Drug Development Tools

https://seetharamkandarpa.webnode.in/news/new-fda-guidance-for-drug-development-tools/

Personal overview of FDA Commissioner Margaret A. Hamburg about visit in India

https://seetharamkandarpa.webnode.in/news/personal-overview-of-fda-commissioner-margaret-a-hamburg-about-visit-in-india/

FDA wants to increase Number of foreign Inspections

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

New FDA Guidance to Avoid Overfill of Vials

https://seetharamkandarpa.webnode.in/news/new-fda-guidance-to-avoid-overfill-of-vials/

New FDA Guideline on Size, Shape and Physical Attributes of Generics

https://seetharamkandarpa.webnode.in/news/new-fda-guideline-on-size-shape-and-physical-attributes-of-generics/

Draft Guideline on Validation of biotechnology-derived Products by EMA

https://seetharamkandarpa.webnode.in/news/draft-guideline-on-validation-of-biotechnology-derived-products-by-ema/

FDA Issues Final Guidance on "Considerations When Transferring Clinical Investigation Oversight to Another IRB"

https://seetharamkandarpa.webnode.in/news/fda-issues-final-guidance-on-considerations-when-transferring-clinical-investigation-oversight-to-another-irb/

FDA Warns German Drugmaker for Potentially Contaminating Products

https://seetharamkandarpa.webnode.in/news/fda-warns-german-drugmaker-for-potentially-contaminating-products/

Mylan launches atovaquone & proguanil hydrochloride tablets

https://seetharamkandarpa.webnode.in/news/mylan-launches-atovaquone-proguanil-hydrochloride-tablets/

FDA Commissioner Margaret Hamburg to Resign Next Month

https://seetharamkandarpa.webnode.in/news/fda-commissioner-margaret-hamburg-to-resign-next-month/

FDA and CMS Form Task Force on LDT Quality Requirements

https://seetharamkandarpa.webnode.in/news/fda-and-cms-form-task-force-on-ldt-quality-requirements/

Recognition of Alternative Compendia (BP/EP/JP) by the FDA

https://seetharamkandarpa.webnode.in/news/recognition-of-alternative-compendia-bp-ep-jp-by-the-fda/