Postmarket Safety

CMS Delays Sunshine Act Reporting Timeline

The Centers for Medicare and Medicaid Services (CMS) has relaxed the deadline for submitting 2013 data under the Physician Payment Sunshine Act, giving drugmakers until late spring to report the details of payment information. Read More

Abbott Hit With Lawsuits As FDA Investigates Androgel Risks

Days after the FDA said it plans to investigate the safety of testosterone replacement drugs, Abbott was hit with five lawsuits claiming the drugmaker marketed Androgel to millions of men who didn’t need it and hid the risks of heart attack and stroke associated with the drug. Read More

MHRA Offers Roadmap for Reporting Drug Defects

The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More