by Tony Chen

The first quarter of 2011 proved to be a busy one for the FDA.  We saw a deputy commissioner resign, a chemist charged for insider trading, a couple of big consent decrees, a big cancer drug approval, a big no-news on social media guidance, and more.  Here’s our wrap-up of the key developments.

General and Organizational

  1. Deputy Commissioner resigns (WSJ 1/5/11)
  2. FDA Tobacco Advisor Resigns for personal reasons (WSJ, 1/5/11)
  3. FDA launches “FDA basics for Industry” microsite (FDA, 1/6/11)
  4. Barack Obama: Towards a 21st-Century Regulatory System (WSJ, 1/18/11)
  5. FDA approves Allegra sale without prescription (WSJ 1/26/11)
  6. FDA pitches 33% budget increase (MassDevice, 2/15/11)
  7. FDA’s facebook page grew past 6,000 fans, growing at about 1,000 new fans per month.
  8. FDA delays providing guidance on social media (again) (MM&M, 3/30/11)
  9. FDA chemist charged for $3M insider-trader scheme;  Puts internal control of key FDA system in spotlight (WSJ 3/31/11)

Drugs

  1. FDA: Pharma drags feet on fast-track cancer drug studies follow-up (FiercePharma, 2/9/11)
  2. Hamburg says biosimilars rule coming soon (RAPS, 2/24/11)
  3. FDA approves billion-dollar cancer drug from BMS (Seeking Alpha 3/28/11)
  4. FDA yanks 500 unapproved cold/allergy meds (FiercePharma, 3/3/11)
  5. FDA allows cheaper version of Makena to stay on the market (WSJ, 3/30/11) (side note: K-V has since slashed their price 55%)

Devices

  1. FDA unveils 25 initial 510(k) changes (McGuire Woods, 1/21/11)
  2. FDA continues to look at re-classifying medical devices (FDAzilla, 2/22/11)
  3. FDA publishes final MDDS rule – signals stronger enforcement (FDAzilla, 3/22/11)
  4. ReGen to FDA: thanks, but no thanks (PRNewsWire, 3/28/11)
  5. FDA clarifies Class II “special controls” medical device guidance (MassDevice, 3/28/11)
  6. FDA clears Abbott’s wireless handheld testing system (MassDevice, 3/29/11)

Food & Tobacco

  1. Historic Food Safety Bill signed into law (Food Safety News, 1/5/11)
  2. FDA will monitor food from Japan (WSJ 3/17/11)  Some foods imported from the nuclear plants have been banned (WSJ 3/23/11)
  3. FDA criticizes menthol cigarettes (WSJ, 3/19/11)
  4. FDA looking at artificial food dyes (WSJ 3/29/11)

Manufacturing and Consent Decrees

  1. FDA announces “Current Good Manufacturing Practice Quality System Regulation” approved by OMB (Federal Register, 1/12/11)
  2. FDA planning more outsourced inspections for international facilities (Bloomberg 2/10/11)
  3. Triad Group’s tainted wipes – FDA new about issues for years? (MSNBC, 2/22/11)
  4. Huge Consent Decree for McNeil (FiercePharmaManufacturing, 3/14/11)
  5. FDA official: Overseas manufacturing puts U.S. at Risk (FiercePharma, 3/15/11)
  6. Consent Decree: Terumo Cardiovascular Systems (FDAzilla,3/23/11)

What developments from the FDA impacted your business the most?

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