FDA Calendars
- BioPharmCatalyst (type PDUFA to filter; or use this)
- RTTNews
- FDATracker
Research
- BioPharmCatalyst: lots of great resources
- Company Investor Relations Webpages: Corporate Presentations, Annual Report, Press Release News etc.
- Academic conferences: ASH, ASCO, AACR presentations and posters
- FDA review documents and AdCom Debrief and presentation
- Academic journal
- Citeline
- SEC filings. Particularly useful for companies that no longer exist or be independent.
- Google Finance; Yahoo Finance; StockCharts.com
- Google: other people's opinions (analysts, laymen, etc.)
- Professional sources: PubMed, clinicaltrials.gov, medical websites in Google results, etc.
- Non-professional sources: seeking alpha, yahoo message board, etc. , good to survey opinions, but be cautious. Lots of emotional, treacherous, false or foolish information, sometimes even disguised as "expert opinion" or "premium research" with obvious garbage research.
- Don't forget the reference folder in project. Save your time!
FDA Drug Approval Process Readings
- FDA Official Info for Consumers
- FDA Official Info for Small Businesses
- A Testimony about Drug Safety and Approval Process in Mar 2005
- Clinical development success rates for investigational drugs. Hay et al. 2014 Nature Biotech. | Supplement
- Scientific and Regulatory Reasons for CRL Sacks et al. 2014 JAMA
- FDA Analysis for Formal Dispute Resolution
- Press releases are incomplete substitutes for the detailed information contained in complete response letters (CRL). Lurie et al. 2015 BMJ
- Enrichment Strategies: FDA Webinar Slides; FDA CDER SB Newsletter; PolicyMed News.
Other Resources
FDA related
- FDAReview.org
- FDA advisory committee meeting outcomes by McKinsey at Nat. Rev. Drug Disc. 2012
- Drug-Review Deadlines and Safety Problems NEJM 2008 | and Correction
- An overview of FDA-approved new molecular entities: 1827–2013. Kinch et a. 2014 Drug Discovery Today.
- Frequently Asked Questions on Patents and Exclusivity
- 22 Case Studies Where Phase 2 and Phase 3 Trials Had Divergent Results by FDA 2017; opinion by Author Peter G. Lurie (COVID)
Websites
Business
- Stock or Cash?: The Trade-Offs for Buyers and Sellers in Mergers and Acquisitions
- Current Partnering Life Science Intelligence for Deal Makers
Finance and Investment
- ‘Index funds beat active 90% of the time.’ Really? By Rob Isbitts @ Market Watch
- How Interest Rates Affect The Stock Market By Jim Mueller @ Investopedia
- Equity Research | A Complete Beginner’s Guide By Dheeraj @ WallStreetMojo
- The Best Way to Improve Investment Skills: “One Case Study After Another” By John Huber @ Base Hit Investing
- 17 red flags to watch with small caps
- Five warning flags for investors in small cap stocks
- IPO: The long run performance of IPO by J.R.Ritter 1991 J.Finance.; 2016 Update.
- With Market Timing, Even If You Win, You Lose (Hint: Taxes)
- Why You Can’t Time the Market: Thoughts on Investing in Stocks
- 邱国鹭:价值投资者如何止损?
- Investing in the Unknown and Unknowable by Richard Zeckhauser (Harvard)
Open Source Tools
- Wealthbot.io: Open source wealth management platform
- JStock: Open source stock market software
- QuantLib: Open source library for quantitative finance