Search Results for Latest News

Showing 1 – 25  of 2100

Fitch Report Says NME Approvals Plummet at FDA in Q1, but FDA Data Paint Alternate Picture By Alexander Gaffney, RAC - Published 14 May 2014

Categories: US, FDA

Tags: New Molecular Entity, NME Approvals, Drug Approvals, Report, Latest News, NME

FDA Re-Recognizes Three Radiology Consensus Standards By Alexander Gaffney, RAC - Published 14 May 2014

Categories: US, FDA, CDRH

Tags: Radiology, Consensus Standards, IEC, Latest News

FDA Adopts Four Changes to the eCTD Application By Alexander Gaffney, RAC - Published 14 May 2014

Categories: US, FDA

Tags: eCTD Backbone, XML, Electronic Common Technical Document, Latest News, eCTD

Regulatory Reconnaissance: Will EU Adaptive Licensing Changes Mean Less Market Exclusivity? (14 May 2014) By Alexander Gaffney, RAC - Published 14 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

FDA Goes into Detail About Generic Drug Stability Testing By Alexander Gaffney, RAC - Published 14 May 2014

Categories: US, FDA, CDER, ICH

Tags: Stability, Q&A, Generic, ANDA, Latest News, pharmaceutical, guidance, drug

Regulatory Reconnaissance: FDA Dials Back on Use of REMS (13 May 2014) By Alexander Gaffney, RAC - Published 13 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

PhRMA, BIO Express Unanimous Concerns About FDA Electronic Submission Guidance Docs By Alexander Gaffney, RAC - Published 13 May 2014

Categories: US, FDA

Tags: Electronic Submissions, BIO, PhRMA, Latest News, eCTD, guidance

APEC Moving Toward 'Regulatory Convergence' in Effort to Safeguard Drugs, Improve Manufacturing By Alexander Gaffney, RAC - Published 13 May 2014

Categories: Asia, APEC, Manufacturing

Tags: Adulterated, Counterfeit, Misbranded, Latest News, regulatory convergence

FDA's Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing By Alexander Gaffney, RAC - Published 13 May 2014

Categories: US, FDA

Tags: Biosimilar Guidance, Biosimilarity, PD, PK, Pharmacology, Latest News, biosimilar, draft guidance

For First Time Since Founding, Government's Mini-Sentinel System Shrinks in Size By Alexander Gaffney, RAC - Published 13 May 2014

Categories: US, FDA

Tags: MSDD, Big Data, Mini-Sentinel, Adverse Event Reporting, AER, Latest News

As Medical Marijuana Hits Mainstream, Regulators Take Notice With Safety Recalls By Alexander Gaffney, RAC - Published 12 May 2014

Categories: Canada, Health Canada

Tags: Medical Marijuana, Contamination, Recall, Latest News

Regulatory Reconnaissance: Mind-Controlled Prosthetic Obtains FDA Approval (12 May 2014) By Alexander Gaffney, RAC - Published 12 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

FDA Teams Up With EU Regulators to Launch New Pharmaceutical Quality Initiative By Alexander Gaffney, RAC - Published 12 May 2014

Categories: Quality, US, FDA

Tags: Dara Corrigan, Drug Quality, OPQ, Pharmaceutical Quality, Latest News

Regulatory Reconnaissance: Merck's Zontivity Approved by FDA (9 May 2014) By Alexander Gaffney, RAC - Published 09 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Regulatory Reconnaissance: Senate to FDA: What's up With These Draft Guidances? (8 May 2014) By Alexander Gaffney, RAC - Published 08 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

FDA Blows Away Rivals in Approving Cancer Therapies By Alexander Gaffney, RAC - Published 08 May 2014

Categories: Japan, US, EMA, FDA, PMDA

Tags: Median Time to Approval, FDA vs PMDA, FDA vs EMA, Time to Approval, Report, Approvals, Latest News, EU

FDA Moves to Close Glaring Loophole in Current Drug Import System By Alexander Gaffney, RAC - Published 07 May 2014

Categories: US, FDA

Tags: Drug Import Regulation, Administrative Detention, 801a, FDASIA, Export, Import, Latest News

Two New Centers of Regulatory Science Excellence Launched by FDA By Alexander Gaffney, RAC - Published 07 May 2014

Categories: US, FDA

Tags: CERSI, Latest News, regulatory science

Regulatory Reconnaissance: FDA Tests Blood Pressure Pills, Citing Concerns About Generics (7 May 2014) By Alexander Gaffney, RAC - Published 07 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

FDA Issues New Draft Guidance on Bacterial Pneumonia Treatments By Alexander Gaffney, RAC - Published 07 May 2014

Categories: US, FDA, CDER

Tags: Pneumonia, Antibiotic, Antibacterial, Latest News, draft guidance, guidance

Have an Idea for a Medical Device Guidance? CDRH Says it Wants to Know By Alexander Gaffney, RAC - Published 07 May 2014

Categories: US, FDA, CDRH

Tags: Latest News, guidance, medical device

FDA Expresses Interest in Comparative Price of Drugs (But not in the way you Think) By Alexander Gaffney, RAC - Published 06 May 2014

Categories: US, FDA

Tags: Cost Comparison, Drug Cost, Drug Pricing, DTC Advertising, Latest News, marketing, advertising

FDA Moves Forward With Drug Labeling Revision Project By Alexander Gaffney, RAC - Published 06 May 2014

Categories: US, FDA, Labeling

Tags: PDLI-EI, Physician Labeling Rule, PLR, Latest News

Regulatory Reconnaissance: AZ's Heart Drug Epanova Wins FDA Approval (6 May 2014) By Alexander Gaffney, RAC - Published 06 May 2014

Categories: News, Regulatory intelligence

Tags: EMA News, FDA News, Regulatory Reconnaissance, Regulatory News, Links, Latest News, regulatory

Warning Letter to Allergy Manufacturer Cites Insects, Unapproved 'Custom Mixes' By Alexander Gaffney, RAC - Published 06 May 2014

Categories: US, FDA

Tags: warning letter, Insect, BLA, Latest News, cGMP