BIO warns members to increase gender diversity; FDA revises guidance to citizen petitions to block abusing the system; FDA finalizes guidance on timing of pediatric studies for atopic dermatitis; FDA finalizes guidance on package type terms and discard statements for injectables; FDA approves first antibiotic under accelerated approval pathway…

DEA reclassifies CBD-containing Epidiolex as Schedule V drug; FDA releases draft guidance on human factors studies; FDA releases draft guidance documents on adaptive clinical trials and master protocols; Study estimates average cost of Phase 3 studies at $19 million; MHRA permits use of eConsent for clinical trials…

FDA issues draft guidance on monetary penalties for failing to report clinical trials; FDA finalizes guidances on Drug Supply Chain and Security Act; FDA recommends new KASA platform to improve review of applications; EMA publishes concept paper on clinical trials in neonates; Australia unveils strategy for engaging with foreign regulators…

Takeda moves its US headquarters from Chicago to Boston area; FDA releases new draft guidance on post-approval changes to drug substances; FDA issues batch of new and revised product-specific guidances; FDA proposes new rule to make FOIA process easier; EC advises sponsors on the effect of Brexit on clinical trials…

Infamous blood-testing company Theranos to dissolve; Otsuka's dose-tracking digital pill to be distributed by Magellan Health; FDA finalizes guidances on nonallergic and allergic rhinitis; FDA releases MAPP on how manufacturing facilities are prioritized for inspections; ICH biopharmaceutics classification system-based biowaivers guideline…

FDA launches pilot program for complex trial designs; FDA to replace analgesic drug development guidance with new guidances; FDA finalizes guidance on physiologically based PK analyses; FDA “redlists” six Asian companies for failing to allow inspections; NICE recommends against reimbursing Gilead’s CAR-T therapy…

FDA issues draft guidance on use of placebo in only certain oncology trials; FDA drafts guidance on developing products for osteoarthritis; FDA finalizes guidance on microdose radiopharmaceutical diagnostic drugs; FDA finalizes guidance on quality attributes of chewables; Health Canada introduces transparency proposals for pharmaceuticals…

Teva wins FDA approval of generic EpiPens; FDA and NIH reduces role of RAC in gene therapy oversight; FDA drafts molecular target list for pediatric cancer drugs; FDA to create framework to evaluate the use of real world evidence; Health Canada proposes “pause the clock” triggers during review of premarket submissions…

FDA drafts guidance on seamless clinical trials for oncology drugs; FDA drafts guidance on endpoints for opioid use disorder; FDA finalizes guidance on dissolution testing and acceptance criteria; FDA calls for industry input on expanding National Drug Code; EC drafts GCP guideline for advanced therapy medicinal products…

FDA seeks feedback on clinical outcome assessments; FDA drafts guidance on nonclinical testing of nicotine products; FDA and EMA to hold workshop on early access approaches; More staff than anticipated quit EMA ahead of Brexit relocation; UK to reschedule cannabis-derived medicinal productsBy Robert Cormack

FDA closes pediatric study loophole in new guidance; FDA publishes surrogate endpoints list for drug approvals; FDA releases draft guidance on single enzyme defects; FDA releases draft guidance on diet in clinical trials; EMA revises guidelines for Crohn’s disease and ulcerative colitisBy Robert Cormack

FDA announces details of major reorganization of CDER; FDA adopts ICH guideline on multiregional clinical trials; FDA issues draft guidance on field alert report submissions; UK votes to remain in EMA after Brexit; EMA finalizes gene therapy guidelineBy Robert Cormack

FDA releases new draft guidances on gene therapy; FDA updates guidance on development of smallpox antivirals; FDA issues draft guidance on hypertension drug development; EMA releases concept paper on drugs to prevent and treat acute kidney injury; Health Canada issues guidance on compliance with notifications of foreign regulatory actions…

GW Pharma wins historic FDA approval for cannabis-based drug; FDA strengthens its workforce using authorities from Cures Act; FDA issues draft guidance on radiopharmaceuticals for cancer; FDA unveils two new programs on quality metrics; ICH adds new members and advances guidance documentsBy Robert Cormack

FDA withdraws guidance document on analytical studies for biosimilars; CBER launches new program for early meetings with developers of biologics; FDA updates guidance on major depressive disorder; FDA updates guidance on user fee waivers, reductions, and refunds for drugs and biologics; EMA updates guidances for industry on Brexit…

FDA issues new guidance on antibiotics for limited patient populations; FDA issues guidance on gathering patient input during drug development; FDA updates inter-center consult request manual for combination products; FDA proposes alternative mechanisms to comply with GMP for combination products; EMA to launch online portal for orphan drug designa…

CDER unveils plans to modernize Office of New Drugs; CDER moves dispute resolution program; FDA releases updated draft guidance on meetings for sponsors of biosimilars; FDA revises draft guidance on fee waivers for qualifying HIV treatments; EMA’s management board provides updates on Brexit and clinical trial portal…

FDA prepares for implementation of "Right-to-Try" law; First U.S. clinical trial of gene editing technology placed on clinical hold; FDA issues draft guidance on including adolescents in adult oncology trials; FDA release two new draft guidance on REMS; FDA adopts ICH guideline on managing post-approval CMC changes…

FDA finalizes anthrax treatment guidance; FDA issues guidance on maximal usage trials for OTC drugs; FDA seeks input on pH-dependent drug-drug interactions; EMA draft guideline for handling and shipping investigational medicines; EC seeks consultation on duplicate Marketing AuthorisationsBy Robert Cormack

FDA approves novel treatment to prevent migraines; FDA names firms accused of stifling generic competitors; FDA proposes amending classification rules for combination products; FDA finalizes guidance on IRB written procedures; EMA adopts ICH guideline on nonclinical evaluation of anticancer drugsBy Robert Cormack