Weekly Highlights: October 31 -November 4

FDA Abuse-Deterrent Standards: “Take Drug Again” Is Emerging As Key To Support ADF Claims; Standardization Will Take Time

Generic Abuse Deterrent Opioids Will Follow “Complex Products” Path Under GDUFA; CMS, VA Urge FDA To Make Generics A Priority

Cempra Solithromycin Will Test Positive Climate For Antibiotics; Worse-Than-Ketek Liver Signal Sets Tough Challenge For Cmte.

The Future of “Price Negotiation”: Breakthrough Drug Price Setting Versus Part D Reinsurance Reform

Weekly Highlights: October 24 - October 28

ICER On NSCLC Drugs: PD-1s/TKIs Better Than Older Chemotherapies But Data Lacking To Compare Which Is Best

Advisory Committee Tracker: Quiet Schedule Looks Like Good News For Roche/Genentech MS Therapy Ocrevus

GDUFA II Transforms Program From Facility- To Product-Based Fees: ANDA Clean-Up Before Oct. 1, Filing Rush Expected After

FDA Expects Generic Drug Approval Wave To “Crest” Heading Into GDUFA II; Important Trend For Drug Pricing Debate

Weekly Highlights: October 17 - October 21

FDA Wants To Move BsUFA II Process As Fast As Possible; Goal Is To Deliver Agreement To Congress By End Of 2016

Eteplirsen Approval Is Not The New “Normal” For Rare Disease Development; FDA Officials Stress Need For “Good Evidence”

FDA Panel Recommends Desmopressin For Nocturia On Modest Efficacy And Unmet Need, But Will The Agency Agree?

Biosimilar Interchangeability Guidance Still a Possibility for 2016; Oncology Providers, Advocates Preparing For New Class

Trump “Doubles Down” On Opioid Policy By Endorsing MAT; Underscores Bipartisan Themes For Pain/Addiction Rx In 2017

FDA’s Califf Explains Eteplirsen Approval: Goal Was To Avoid “Meddling”; Urges “Constructive” Patient Input

Allergan/Serenity Desmopressin For Nocturia: Hyponatremia, Modest Efficacy May Keep Committee Up At Night

Immuno-Oncology Trials: FDA Thinking Ahead for Endpoints Beyond Survival; AACR Workshop Outlines Initial Ideas

GDUFA II Commitment Letter Confirms ANDA Reviews Will Be Core Focus; Foreign Inspections No Longer Emphasized

Drug Pricing Themes In 2017: Three Threats To Worry About – But Medicare Price Negotiation Isn’t One Of Them

FDA, Johns Hopkins CERSI to Hold Workshop on Substitutability of Generic Drugs, Surveillance and Monitoring Tools

Weekly Highlights: October 11 - October 14

“21st Century Cures” In The Lame Duck: Bipartisan Push Gives Bill A Chance; Antibiotic Provisions, Vouchers Likely To Survive

FDA’s Temple Says Surrogate Biomarker Use Plays Key Role In Disease Modifying Drug Development In Neurology, Not Symptom Treatment