Prevision Policy Clips | Apotex Potassium Chloride Becomes First CGT Approved, Follows Amneal ANDA Approval

Paratek’s Omadacycline Clears Advisory Committee Meeting For ABSSSI and CABP; Panelists Push for Randomized Postmarketing Trial to Look at Mortality Imbalance

Opioid Use Disorder Guidance: FDA Expands Clinical Endpoints, Builds On April PFDD Meeting

FDA Wants You: Streamlined Hiring Pilot Kicks Off After Delay, Recruiting For “Cures”-Funded Positions Restarts After HHS Review

Prevision Policy Clips | Express Scripts’ 2019 Preferred Formulary Excludes Gilead’s HIV drug Atripla

Insmed’s Amikacin Inhaled Antibiotic Wins Support From FDA Advisory Committee For Use In Refractory Patients; Surrogate Endpoint Is More Of A Question Mark

CMS To Allow Step Therapy In Part B For MA Plans In 2019, Targeting $2.4 Bil. In Annual Savings

TIRF REMS Will Be Modified To Address “Gaps” As Program Oversight Receives Commissioner-Level Attention

Broad Range of FDA Participants Get Platform At Alport Syndrome PFDD Meeting

Prevision Policy Clips | Elemental Impurities Final Guidance

Paratek’s Omadacycline for ABSSSI and CABP: Positive Panel Review Likely for Both Uses But FDA Notes Mortality Imbalance in Pneumonia Trial

Prevision Policy Clips | Remoxy Receives Fourth FDA “Complete Response”

Insmed Inhaled Antibiotic Advisory Committee Centers On Strength Of Surrogate Endpoint: FDA Looking At Non-RCT Supportive Data; Seeks Outside Confirmation

Prevision Policy Clips | CMS Gives Matching Add-On Payments for Novartis/Gilead CAR-Ts

Novartis and Gilead CAR-Ts Get Add-On Payments, But New DRG Model Deferred; CMS Also More Amenable To New Antibiotics

Prevision Policy Clips | ICER to Review Spinal Muscular Atrophy Treatments In March 2019

TIRF Wars: REMS For IR Transmucosal Fentanyl May Not Be A Model After All; Concerns Remain On Patient Selection

Prevision Policy Clips | Advancing Pediatric Pharmacovigilance Workshop September 14

FDA Looks To Expand Scope Of Sentinel Data By Adopting Machine Learning Practices To Paper/PDF Health Records

Advisory Committee Tracker: So Many Approvals, So Few Advisory Committees

FDA Seeking More Real-World Evidence Proposals From Sponsors; Ad Hoc Projects Precede General Guidances

Prevision Policy Clips | NDA User Fee Increases To $2.59 Million For Fiscal 2019

Prevision Policy Clips | FDA Biosimilar Fee Notice Hints At Surge In Approvals

Prevision Policy Clips | 60 Degrees Pharma Tafenoquine for Malaria Prophylaxis Gets Positive Advisory Committee Recommendation

60 Degrees Pharma Tafenoquine for Malaria Prophylaxis Likely To Follow GSK’s Treatment Version To Market Soon, Following Positive Advisory Committee