The Association for Accessible Medicines (AAM) Biosimilars Council’s recent white paper recommends the FDA streamline its regulation of biosimilar development to allow more affordable biologics products to the market more…
Two devicemakers in Mississauga, Ontario — Techlem Medical and Trexo Robotics Holdings — received recently released FDA Warning Letters with Techlem cited for quality issues and Trexo for marketing unapproved…
Members of the FDA’s Psychopharmacological Drugs Advisory Committee voted strongly against recommending MDMA, also known as “ecstasy,” as a potential treatment for post-traumatic stress disorder (PTSD) at their meeting on…
The 340B Drug Discount Program needs more regulation, oversight and transparency to combat abuse by bad actors, according to members of the House Energy and Commerce Committee’s Oversight and Investigations…
Inadequate personnel training, non-implementation of quality control procedures and scuttle fly larva found on employee clothing are among the litany of observations from an FDA Form 483 levied on Shanghai-based…
The FDA has released two draft guidances on how sponsors can prepare for bioresearch monitoring inspections (BIMO) in both their marketing applications as well as prior to and during the…
Novartis has taken up the legal sword against Maryland and West Virginia over state legislation that would widen the powers of the controversial 340B program. Source: Drug Industry Daily
More than 70,000 Zantac cases may go to trial following Delaware Superior Court Judge Vivian Medinilla’s order allowing plaintiffs’ expert witnesses to testify in court that the drug may cause…
In responding to an FTC/HHS request for information (RFI) on how drug wholesalers and group purchasing organizations (GPOs) influence generic drug shortages, the trade group for generic and biosimilar drug…
How can regulators judge the efficacy and safety of a product that makes patients feel so good, so quickly, that trial blinding is impossible, and the drug’s positive effects may…