Quicksand Pharma/Biotech Weekly News

GW Pharma wins historic FDA approval for cannabis-based drug; FDA strengthens its workforce using authorities from Cures... Read more

FDA releases new draft guidances on gene therapy; FDA updates guidance on development of smallpox antivirals; FDA issues... Read more

FDA announces details of major reorganization of CDER; FDA adopts ICH guideline on multiregional clinical trials; FDA is... Read more

FDA drafts guidance on seamless clinical trials for oncology drugs; FDA drafts guidance on endpoints for opioid use diso... Read more

FDA launches pilot program for complex trial designs; FDA to replace analgesic drug development guidance with new guidan... Read more

Teva wins FDA approval of generic EpiPens; FDA and NIH reduces role of RAC in gene therapy oversight; FDA drafts molecul... Read more

FDA issues draft guidance on use of placebo in only certain oncology trials; FDA drafts guidance on developing products ... Read more

FDA seeks feedback on clinical outcome assessments; FDA drafts guidance on nonclinical testing of nicotine products; FDA... Read more

FDA closes pediatric study loophole in new guidance; FDA publishes surrogate endpoints list for drug approvals; FDA rele... Read more

FDA withdraws guidance document on analytical studies for biosimilars; CBER launches new program for early meetings with... Read more

FDA issues new guidance on antibiotics for limited patient populations; FDA issues guidance on gathering patient input d... Read more

CDER unveils plans to modernize Office of New Drugs; CDER moves dispute resolution program; FDA releases updated draft g... Read more

FDA prepares for implementation of "Right-to-Try" law; First U.S. clinical trial of gene editing technology placed on cl... Read more

FDA finalizes anthrax treatment guidance; FDA issues guidance on maximal usage trials for OTC drugs; FDA seeks input on ... Read more

FDA approves novel treatment to prevent migraines; FDA names firms accused of stifling generic competitors; FDA proposes... Read more

BIO warns members to increase gender diversity; FDA revises guidance to citizen petitions to block abusing the system; F... Read more

DEA reclassifies CBD-containing Epidiolex as Schedule V drug; FDA releases draft guidance on human factors studies; FDA ... Read more

FDA issues draft guidance on monetary penalties for failing to report clinical trials; FDA finalizes guidances on Drug S... Read more

Takeda moves its US headquarters from Chicago to Boston area; FDA releases new draft guidance on post-approval changes t... Read more

Infamous blood-testing company Theranos to dissolve; Otsuka's dose-tracking digital pill to be distributed by Magellan H... Read more