We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act. Read More
Type IB variations must be notified to the relevant national authorities or the EMA prior to implementation but they are not subject to formal approval. Read More
The Hatch-Waxman Act did not strike a good balance between generic access and brand-name innovation, according to public comments to the FDA from both PhRMA and the Association for Accessible Medicines — however the two groups disagree as to how. Read More
The FDA finalized guidance for manufacturers looking to produce generic versions of opioid painkillers with abuse-deterrent labeling, as a part of the agency’s push to lower overall exposure to opioids and prevent new addictions. Read More
New York’s attorney general indicted a pharmacy owner, pharmacist and three pharmacies for defrauding Medicaid of $3 million in reimbursements for drugs that were never dispensed. Read More
The European Union landed on Amsterdam as the new home for the European Medicines Agency headquarters, following three rounds of voting and a tiebreaker against Milan. The agency hopes to keep a majority of its existing staff in the move. Read More
The Federal Circuit eased the ability for patent holders to amend their claims when challenged under inter partes review — a hurdle that pharmaceutical industry trade groups had previously described as unfair, ambiguous and impractical. Read More
The trade association of the British drug industry dropped its legal challenge to new guidelines from national regulators that subject higher-priced drugs to an extra review under England’s single-payer National Health Service. Read More