Newsletter
Title Month Download
Strategy to make India major bio-manufacturing hub Jan 2016 Download
Canada’s CCAB eyes Indian bio-pharma to maximise its biological expertise for manufacture of antibody-based drugs Oct 2015 Download
LOTUS LABS - MIDYEAR UPDATES: Jul 2015 Download
US FDA finalizes three guidance documents tied to bio-similar science, quality Jun 2015 Download
US FDA finalizes three guidance documents tied to bio-similar science, quality May 2015 Download
US FDA issues draft guidance on formal meetings for applicants of PDUFA products Apr 2015 Download
Government to frame guidelines for companies to set up pharmacovigilance system Mar 2015 Download
Panel for D&C Rule amendments forms 7 sub-groups on drugs, medical dev ices, clinical trials, biologicals, etc Feb 2015 Download
Clinical trial regulations to be developed through consultative approach Jan 2015 Download
Apex committee on clinical trials grants approval to 28 proposals Dec 2014 Download
Lotus Labs at Global Generics & Biosimilars Awards 2014 Nov 2014 Download
Apex committee on clinical trials gives approval to 33 proposals of clinical trials Nov 2014 Download
New EMA trial transparency policy may mean higher legal costs for CROs say campaigners Oct 2014 Download
Changing Clinical Trial Regulatory Scenario In India. Sep 2014 Download
US FDA issues draft norms on reference product exclusivity for biologicals to determine date of first licensure. Aug 2014 Download
Indian clinical trial approvals see early spike in 2014. Jul 2014 Download
We greatly value your continued association with us. Please find the newsletter for this month. Hope you find the content interesting and useful. Jun 2014 Download
DCGI lays down special conditions to allow import of drugs with residual life less than mandated 60% May 2014 Download
India becomes 7th largest contributor to WHO-UMCs international drug safety database Apr 2014 Download
US FDA to reduce backlog of generic drug applications, increase inspections Mar 2014 Download
DCGI not to approve BA/BE studies conducted at clinical or bioanalytical facilities not approved by CDSCO Feb 2014 Download
European Commission issues GDP norms,Indian pharma conform to new rules Jan 2014 Download
US FDA issues rules on Electronic Source Data in Clinical Investigations;Indian CROs view it platform to prove proofs Dec 2013 Download
US FDA seeks industrys comments on new draft norms on ANDA submissions Nov 2013 Download
US FDA norms for clinical investigators, sponsors & to ascertain need for human studies for IND Oct 2013 Download
US FDA issues norms on delaying a drug inspection,waits industry comments Sep 2013 Download
US FDA calls industry developing Rheumatoid Arthritis drugs to focus on dosing regimen, efficacy Aug 2013 Download
Nearly 500 ethics committees registered after CDSCO made it mandatory in Feb, 2013 Jul 2013 Download
US FDA issues draft guideline on expanded access to IND for treatment Jun 2013 Download
Indian pharma expects US FDAs SUPAC Mfg Eqpt Addendum to boost global regulatory compliance May 2013 Download
Commerce ministry may step up MAI sops to exporters to cope with burden of GDUFA Apr 2013 Download
CDSCO issues comprehensive list of FDCs approved by DCGI since 1961 till Feb, 2013 Mar 2013 Download
Nearly 500 ethics committees registered after CDSCO made it mandatory in Feb, 2013 Feb 2013 Download