Drugs and Pharmaceuticals Industry Terminology

Company filed an ANDA for generic atorvastatin; The ANDA included a Paragraph IV challenge to the Orange Book patent; FDA issued a Complete Response Letter on the ANDA due to CMC deficiencies.

FDA granted accelerated approval based on tumor response rate; The label notes approval under the accelerated approval pathway; Sponsor initiated a confirmatory Phase 3 study to verify benefit.

API synthesis was transferred to a new CMO; API purity specification set at not less than 99.0% by HPLC; API scale-up from 10 kg to 200 kg per batch.

Headache was the most common AE in Phase 2; All serious AEs must be reported within 24 hours; The DSMB reviewed AE rates and recommended continuing the trial.

The new formulation improved oral bioavailability from 35% to 60%; High-fat meals reduced bioavailability by 20%; IV reference enabled calculation of absolute bioavailability.

Company plans to file a BLA for its monoclonal antibody in Q4; The BLA pre-approval inspection identified no 483 observations; FDA accepted the 351(k) BLA for a proposed biosimilar.

PD-L1 expression served as a predictive biomarker; Reduction in CRP was used as a pharmacodynamic biomarker; The FDA-qualified biomarker accelerated patient selection.

Our asset’s BT designation allows more frequent FDA interactions; Breakthrough status enabled rolling review of the NDA; The stock rose after the program received BTD.

CMC Module 3 of the eCTD was updated for a new API supplier; Process validation is a key CMC milestone prior to filing; CMC comparability was required after a scale-up change.

Overall survival is the primary clinical endpoint; The trial failed to meet its primary endpoint of HbA1c reduction; Patient-reported outcomes served as secondary clinical endpoints.

FDA placed the IND on clinical hold after a liver toxicity signal; A partial hold limited dosing above 100 mg; The hold was lifted after submitting additional nonclinical data.

Therapy requires a companion diagnostic to detect EGFR mutations; CDx and drug were co-developed and co-labeled; Reimbursement hinges on availability of the approved CDx.

We engaged a CRO to run our global Phase 2 program; CRO oversight is a key sponsor responsibility under GCP; The CRO provided FSP resources for biostatistics.

A cGMP deviation triggered a product recall; The facility operates under 21 CFR Parts 210 and 211; EU cGMP requires QP certification for batch release.

Data exclusivity delays ANDA approvals despite patent expiry; EU offers 8+2+1 years of data and market protection; 505(b)(2) applications may rely partly on published data.

Our ANDA references a Type II DMF for the API; The DMF holder issued a Letter of Authorization; FDA requested an update to the excipient DMF.

Publishing the eCTD required granularity per ICH guidelines; A new sequence was submitted to address the CRL; The agency rejected the submission due to eCTD technical errors.

EMA’s CHMP issued a positive opinion; We will pursue the centralized procedure via EMA; Post-authorization safety studies were requested by EMA.

Fast Track enabled earlier submission of CMC sections; The asset has both Fast Track and Orphan designation; Fast Track does not guarantee Priority Review.

The FIH SAD/MAD study enrolled healthy volunteers; Dose escalation was guided by a Bayesian model; Sentinel dosing was used in the first cohort.

FDA issued a Complete Response Letter on the NDA; A Type C meeting with FDA is scheduled; PDUFA timelines guide FDA review milestones.

Switching to an amorphous solid dispersion improved solubility; A pediatric formulation was developed as an oral suspension; Excipient compatibility studies informed the formulation.

AB-rated generics were launched at 80% discount; The generic failed bioequivalence on Cmax; Authorized generic entry eroded brand share.

The audit found GCP noncompliance in informed consent documentation; The TMF must demonstrate GCP compliance; Investigator training on ICH E6(R2) was completed.

The 28-day tox study was conducted under GLP; QA audited the GLP facility; Raw data archiving is a GLP requirement.

A Paragraph IV challenge under Hatch-Waxman triggered litigation; The 30-month stay delayed generic entry; The act enables 505(b)(2) approvals.

NICE’s HTA recommended use with a managed access agreement; HTA dossiers include cost-effectiveness models; Local HTA outcomes impact market access timelines.

The IVD detects BRAF mutations for therapy selection; CE-IVD marking is required in the EU; The LDT will transition to an FDA-cleared IVD.

We filed a composition-of-matter patent and method-of-use claims; Freedom-to-operate analysis guided the formulation choice; SPC filings extend protection in the EU.

The IND became effective after the 30-day review; An IND amendment added a new cohort; A safety update was filed to the IND.

A KOL advisory board refined the target product profile; Engagement with KOLs supported publication planning; KOLs presented Phase 3 data at a major congress.

The USPI includes a boxed warning for hepatotoxicity; Dosage and administration were updated via sNDA; The medication guide is part of the labeling.

We out-licensed APAC rights with tiered royalties; The in-licensing deal included double-digit milestones; Territory splits and field of use were key terms.

An extended-release formulation is part of the LCM plan; A pediatric sNDA can add 6 months of exclusivity; The brand pursued a device-enabled combination for LCM.

Early HEOR informed the market access strategy; The product secured preferred formulary status; Access was restricted via prior authorization.

The MoA is EGFR tyrosine kinase inhibition; MoA differentiation supports positioning against competitors; Biomarker changes confirm the proposed MoA.

Medical Affairs led advisory boards and congress strategy; MSLs engaged KOLs with balanced, non-promotional discussion; An IIT program generated real-world data.

Portfolio decisions were based on rNPV and strategic fit; A delay reduced NPV due to lost exclusivity time; Sensitivity analysis tested NPV against price and uptake.

The NDA received Priority Review with a 6-month clock; FDA issued a label negotiation letter on the NDA; A CRL required additional CMC data.

The 2-species GLP tox package supported the IND; Safety pharmacology included CV, respiratory, and CNS studies; A carcinogenicity assessment was waived.

Orphan designation provides 7 years of US exclusivity; The program reduces PDUFA fees; EMA orphan status offers protocol assistance.

The company is approaching a 2027 patent cliff; LCM aims to soften the cliff with a new combo; Generic erosion exceeded 80% within a year.

PopPK modeling supported dose selection; Exposure-response analysis linked AUC to efficacy; Therapeutic drug monitoring is guided by PK/PD targets.

All ICSRs are processed in the safety database; Signal detection led to a new warning; PBRER/PSUR submissions were scheduled with EMA.

PBM rebate negotiations determined net price; Step therapy requirements were imposed by the PBM; Exclusion from the PBM formulary hurt uptake.

The PDUFA date is set for October 15; Under PDUFA VII, FDA committed to new review goals; A 3-month extension moved the PDUFA goal date.

CQAs and CPPs were defined under QbD principles; Design space was established via DoE; The control strategy derives from the QbD risk assessment.

The Phase 3 RCT met its primary endpoint; Randomization was stratified by baseline severity; The DSMB reviewed interim RCT data.

RWE supported label expansion for a new population; A retrospective cohort from EHRs assessed outcomes; The RWE plan was aligned with regulators early.

The product launched with a REMS requiring prescriber certification; REMS modifications were negotiated with FDA; Failure to comply with REMS can lead to enforcement.